<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203630</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 140141</org_study_id>
    <secondary_id>UL1RR024975-01</secondary_id>
    <secondary_id>UL1TR000445-06</secondary_id>
    <nct_id>NCT02203630</nct_id>
  </id_info>
  <brief_title>Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients</brief_title>
  <official_title>A Randomized Controlled Pilot Trial of Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Research Resources (NCRR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Septic shock is a condition that is marked by severe infection causing hypotension requiring&#xD;
      vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign,&#xD;
      an international organization formed for the purpose of guiding the management of sepsis and&#xD;
      septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic&#xD;
      shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as&#xD;
      an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate&#xD;
      cardiac complications. This recommendation is based solely on experience with no scientific&#xD;
      evidence to support this recommendation.&#xD;
&#xD;
      The investigators will conduct an open-label randomized controlled trial (RCT) directly&#xD;
      comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used&#xD;
      in clinical practice for the management of septic shock. The investigators will perform this&#xD;
      study with a population of patients that have septic shock to complete the following aims:&#xD;
&#xD;
      Aim 1: Determine the incidence of tachyarrhythmias.&#xD;
&#xD;
      Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a&#xD;
      lower heart rate.&#xD;
&#xD;
      Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a&#xD;
      higher incidence of new tachyarrhythmias.&#xD;
&#xD;
      Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less&#xD;
      time in tachyarrhythmia.&#xD;
&#xD;
      Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer&#xD;
      complications, including cardiac complications.&#xD;
&#xD;
      The investigators hypothesize that in this setting, phenylephrine will improve the management&#xD;
      of septic shock when used as a &quot;first choice&quot; vasopressor by:&#xD;
&#xD;
        1. Decreasing the mean heart rate&#xD;
&#xD;
        2. Decreasing the incidence of new tachyarrhythmias&#xD;
&#xD;
        3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new&#xD;
           onset and recurrent tachyarrhythmias&#xD;
&#xD;
        4. Decreasing the number of cardiac complications&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow enrollment; Lack of support and equipoise&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Heart Rate</measure>
    <time_frame>Up to 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Arrhythmia Events</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Time in Arrhythmia</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With ST-segment Abnormalities on ECG</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>ST Elevation of 1 mm in 2 or more consecutive leads or Horizontal or downsloping ST depression of 1 mm in 2 or more consecutive leads</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Uses of Rate-controlling Agent</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Times an Anti-arrhythmic Agent is Used</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Corticosteroid</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>number of days participants received a corticosteroid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Direct Current (DC) Cardioversion Events</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Mechanical Ventilation Needed</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Hemodialysis Needed</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Sequential Organ Failure Assessment (SOFA) Score</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Developing Peripheral Limb Ischemia</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Cardiac Arrest Events</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Without Vasopressor Use</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Shock free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Without Mechanical Ventilation</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Mechanical ventilation-free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days Without Dialysis</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Dialysis-free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Days Not in ICU</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>ICU free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days Spent Out of the Hospital</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Hospital free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission to ICU</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Rehospitalized After Discharge</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU Stay</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day Mortality</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Location of Death</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause of Death</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Troponin-I</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>From chart review (if available)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CK-MB</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>From chart review (if available)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine Kinase (CK)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>From chart review (if available)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Receiving Non-study Vasopressors</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Time Non-study Vasopressors Used</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean Blood Pressure (Maximum and Minimum)</measure>
    <time_frame>Up to 28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mean Central Venous Pressure</measure>
    <time_frame>Up to 28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mean Metabolic Panel Laboratory Values</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>From chart review (if available)</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Central Venous Oxygen Saturation</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>From chart review (if available)</description>
  </other_outcome>
  <other_outcome>
    <measure>Anti-hypertensive Agents Used</measure>
    <time_frame>Up to 28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Diuretic Agents Used</measure>
    <time_frame>Up to 28 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Inotropes Used</measure>
    <time_frame>Up to 28 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Septic Shock</condition>
  <condition>Sepsis</condition>
  <condition>Shock</condition>
  <condition>Tachycardia</condition>
  <condition>Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Phenylephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Norepinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
    <arm_group_label>Phenylephrine</arm_group_label>
    <other_name>Neosynephrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
    <arm_group_label>Norepinephrine</arm_group_label>
    <other_name>Levophed</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years of age or greater&#xD;
&#xD;
          -  Intention to treat with vasopressor for diagnosis of septic shock&#xD;
&#xD;
          -  Exclusion criteria not met&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergent indication for surgery&#xD;
&#xD;
          -  Patient possesses a terminal condition for which patient or medical decision maker has&#xD;
             decided to de-escalate medical care (patients with Do Not Resuscitate order but for&#xD;
             whom standard care is continued will not be excluded)&#xD;
&#xD;
          -  Known allergy to phenylephrine or norepinephrine&#xD;
&#xD;
          -  Treated with vasopressor &gt;12 hours for current episode of shock&#xD;
&#xD;
          -  Preference of specific vasopressor agent by patient's provider&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raj Keriwala, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>April 4, 2018</results_first_submitted>
  <results_first_submitted_qc>May 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 13, 2018</results_first_posted>
  <last_update_submitted>May 15, 2018</last_update_submitted>
  <last_update_submitted_qc>May 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Septic shock</keyword>
  <keyword>Vasopressor Agents</keyword>
  <keyword>Phenylephrine</keyword>
  <keyword>Norepinephrine</keyword>
  <keyword>Tachycardia</keyword>
  <keyword>Heart Rate</keyword>
  <keyword>Arrhythmia</keyword>
  <keyword>Catecholamine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Norepinephrine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Phenylephrine</title>
          <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
        </group>
        <group group_id="P2">
          <title>Norepinephrine</title>
          <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Phenylephrine</title>
          <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
        </group>
        <group group_id="B2">
          <title>Norepinephrine</title>
          <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" lower_limit="47" upper_limit="84"/>
                    <measurement group_id="B2" value="58.4" lower_limit="47" upper_limit="73"/>
                    <measurement group_id="B3" value="60.4" lower_limit="47" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart Rate</title>
          <units>beats/minute</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86.3" lower_limit="60" upper_limit="119"/>
                    <measurement group_id="B2" value="97.3" lower_limit="60" upper_limit="132"/>
                    <measurement group_id="B3" value="92.4" lower_limit="60" upper_limit="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Blood Pressure</title>
          <units>mm/Hg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.4" lower_limit="51" upper_limit="95"/>
                    <measurement group_id="B2" value="66.2" lower_limit="54" upper_limit="79"/>
                    <measurement group_id="B3" value="66.7" lower_limit="51" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Heart Rate</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Heart Rate</title>
          <units>beats/minute</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.7" lower_limit="65" upper_limit="132"/>
                    <measurement group_id="O2" value="108.6" lower_limit="57" upper_limit="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Arrhythmia Events</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Arrhythmia Events</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Time in Arrhythmia</title>
        <time_frame>Up to 28 days</time_frame>
        <population>only participants with arrhythmias included</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Total Time in Arrhythmia</title>
          <population>only participants with arrhythmias included</population>
          <units>minutes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>atrial fibrillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1224"/>
                    <measurement group_id="O2" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other (undetermined) arrthymia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With ST-segment Abnormalities on ECG</title>
        <description>ST Elevation of 1 mm in 2 or more consecutive leads or Horizontal or downsloping ST depression of 1 mm in 2 or more consecutive leads</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With ST-segment Abnormalities on ECG</title>
          <description>ST Elevation of 1 mm in 2 or more consecutive leads or Horizontal or downsloping ST depression of 1 mm in 2 or more consecutive leads</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Uses of Rate-controlling Agent</title>
        <description>includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Uses of Rate-controlling Agent</title>
          <description>includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil</description>
          <units>number of uses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Times an Anti-arrhythmic Agent is Used</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times an Anti-arrhythmic Agent is Used</title>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Corticosteroid</title>
        <description>number of days participants received a corticosteroid</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Corticosteroid</title>
          <description>number of days participants received a corticosteroid</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Direct Current (DC) Cardioversion Events</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Direct Current (DC) Cardioversion Events</title>
          <units>DC cardioversion events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Mechanical Ventilation Needed</title>
        <time_frame>Up to 28 days</time_frame>
        <population>only participants that required mechanical ventilation</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Mechanical Ventilation Needed</title>
          <population>only participants that required mechanical ventilation</population>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Hemodialysis Needed</title>
        <time_frame>Up to 28 days</time_frame>
        <population>only participants that required dialysis</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Hemodialysis Needed</title>
          <population>only participants that required dialysis</population>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Sequential Organ Failure Assessment (SOFA) Score</title>
        <description>Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality</description>
        <time_frame>Up to 28 days</time_frame>
        <population>data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Sequential Organ Failure Assessment (SOFA) Score</title>
          <description>Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality</description>
          <population>data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Developing Peripheral Limb Ischemia</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Developing Peripheral Limb Ischemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Cardiac Arrest Events</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cardiac Arrest Events</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Without Vasopressor Use</title>
        <description>Shock free days</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Without Vasopressor Use</title>
          <description>Shock free days</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Without Mechanical Ventilation</title>
        <description>Mechanical ventilation-free days</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Without Mechanical Ventilation</title>
          <description>Mechanical ventilation-free days</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days Without Dialysis</title>
        <description>Dialysis-free days</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Days Without Dialysis</title>
          <description>Dialysis-free days</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Days Not in ICU</title>
        <description>ICU free days</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Days Not in ICU</title>
          <description>ICU free days</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days Spent Out of the Hospital</title>
        <description>Hospital free days</description>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Days Spent Out of the Hospital</title>
          <description>Hospital free days</description>
          <units>days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Readmission to ICU</title>
        <time_frame>Up to 28 days</time_frame>
        <population>data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Readmission to ICU</title>
          <population>data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Rehospitalized After Discharge</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Rehospitalized After Discharge</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of ICU Stay</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Length of ICU Stay</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="O2" value="5.2" lower_limit="2" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="4" upper_limit="26"/>
                    <measurement group_id="O2" value="8.9" lower_limit="3" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>28-day Mortality</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>28-day Mortality</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Location of Death</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Location of Death</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ICU</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not recorded</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cause of Death</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Cause of Death</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>E. coli bacteremia, aspiration pnemonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory failure,hospital aquired pneumonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>septic shock</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoxemic respiratory failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Troponin-I</title>
        <description>From chart review (if available)</description>
        <time_frame>Up to 28 days</time_frame>
        <population>patients with troponin levels</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Troponin-I</title>
          <description>From chart review (if available)</description>
          <population>patients with troponin levels</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" lower_limit="0.22" upper_limit="0.22"/>
                    <measurement group_id="O2" value="0.38" lower_limit="0.1" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CK-MB</title>
        <description>From chart review (if available)</description>
        <time_frame>Up to 28 days</time_frame>
        <population>patients with CK-MB levels</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>CK-MB</title>
          <description>From chart review (if available)</description>
          <population>patients with CK-MB levels</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.87" lower_limit="8.87" upper_limit="8.87"/>
                    <measurement group_id="O2" value="5.07" lower_limit="5.07" upper_limit="5.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Creatinine Kinase (CK)</title>
        <description>From chart review (if available)</description>
        <time_frame>Up to 28 days</time_frame>
        <population>patients with CK levels</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Creatinine Kinase (CK)</title>
          <description>From chart review (if available)</description>
          <population>patients with CK levels</population>
          <units>units/L</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="738" lower_limit="738" upper_limit="738"/>
                    <measurement group_id="O2" value="6986.6" lower_limit="242" upper_limit="13211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Receiving Non-study Vasopressors</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving Non-study Vasopressors</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Time Non-study Vasopressors Used</title>
        <time_frame>Up to 28 days</time_frame>
        <population>participants receiving non-study vasopressors</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Time Non-study Vasopressors Used</title>
          <population>participants receiving non-study vasopressors</population>
          <units>hours</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Phenylephrine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Norepinephrine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasopressin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Epinephrine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Blood Pressure (Maximum and Minimum)</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure (Maximum and Minimum)</title>
          <units>mm/Hg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>minimum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.8" lower_limit="40" upper_limit="63"/>
                    <measurement group_id="O2" value="53.8" lower_limit="42" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>maximum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.6" lower_limit="77" upper_limit="109"/>
                    <measurement group_id="O2" value="79.5" lower_limit="71" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Central Venous Pressure</title>
        <time_frame>Up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Central Venous Pressure</title>
          <units>mm/Hg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="7" upper_limit="14"/>
                    <measurement group_id="O2" value="11.7" lower_limit="7" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Metabolic Panel Laboratory Values</title>
        <description>From chart review (if available)</description>
        <time_frame>Up to 28 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Central Venous Oxygen Saturation</title>
        <description>From chart review (if available)</description>
        <time_frame>Up to 28 days</time_frame>
        <population>patients with central venous pressure readings</population>
        <group_list>
          <group group_id="O1">
            <title>Phenylephrine</title>
            <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
          <group group_id="O2">
            <title>Norepinephrine</title>
            <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Central Venous Oxygen Saturation</title>
          <description>From chart review (if available)</description>
          <population>patients with central venous pressure readings</population>
          <units>mm/Hg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="7" upper_limit="14"/>
                    <measurement group_id="O2" value="11.7" lower_limit="7" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Anti-hypertensive Agents Used</title>
        <time_frame>Up to 28 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Diuretic Agents Used</title>
        <time_frame>Up to 28 days</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Inotropes Used</title>
        <time_frame>Up to 28 days</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Adverse Events and Serious adverse events will not include organ failure or death that is related to septic shock, which are expected complications in this population, unless they are more severe than is expected or unusual in their happenstances.</desc>
      <group_list>
        <group group_id="E1">
          <title>Phenylephrine</title>
          <description>Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Phenylephrine: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
        </group>
        <group group_id="E2">
          <title>Norepinephrine</title>
          <description>Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock&#xD;
Norepinephrine: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was terminated early due to slow enrollment, lack of support and equipoise. PI left Vanderbilt and the record was completed with data recorded in REDCap.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Raj Keriwala</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-322-3412</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203630
org study id: IRB 140141
secondary id: UL1RR024975-01
secondary id: UL1TR000445-06
nct id: NCT02203630
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Septic shock is a condition that is marked by severe infection causing hypotension requiring
      vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign,
      an international organization formed for the purpose of guiding the management of sepsis and
      septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic
      shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as
      an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate
      cardiac complications. This recommendation is based solely on experience with no scientific
      evidence to support this recommendation.

      The investigators will conduct an open-label randomized controlled trial (RCT) directly
      comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used
      in clinical practice for the management of septic shock. The investigators will perform this
      study with a population of patients that have septic shock to complete the following aims:

      Aim 1: Determine the incidence of tachyarrhythmias.

      Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a
      lower heart rate.

      Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a
      higher incidence of new tachyarrhythmias.

      Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less
      time in tachyarrhythmia.

      Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer
      complications, including cardiac complications.

      The investigators hypothesize that in this setting, phenylephrine will improve the management
      of septic shock when used as a "first choice" vasopressor by:

        1. Decreasing the mean heart rate

        2. Decreasing the incidence of new tachyarrhythmias

        3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new
           onset and recurrent tachyarrhythmias

        4. Decreasing the number of cardiac complications
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Heart Rate
time frame: Up to 28 days
measure: Number of Participants With Arrhythmia Events
time frame: Up to 28 days
measure: Total Time in Arrhythmia
time frame: Up to 28 days
measure: Number of Patients With ST-segment Abnormalities on ECG
time frame: Up to 28 days
description: ST Elevation of 1 mm in 2 or more consecutive leads or Horizontal or downsloping ST depression of 1 mm in 2 or more consecutive leads
measure: Number of Uses of Rate-controlling Agent
time frame: Up to 28 days
description: includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil
measure: Number of Times an Anti-arrhythmic Agent is Used
time frame: Up to 28 days
measure: Use of Corticosteroid
time frame: Up to 28 days
description: number of days participants received a corticosteroid
measure: Number of Direct Current (DC) Cardioversion Events
time frame: Up to 28 days
measure: Number of Days Mechanical Ventilation Needed
time frame: Up to 28 days
measure: Number of Days Hemodialysis Needed
time frame: Up to 28 days
measure: Mean Sequential Organ Failure Assessment (SOFA) Score
time frame: Up to 28 days
description: Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality
measure: Number of Participants Developing Peripheral Limb Ischemia
time frame: Up to 28 days
measure: Number of Participants With Cardiac Arrest Events
time frame: Up to 28 days
measure: Number of Days Without Vasopressor Use
time frame: Up to 28 days
description: Shock free days
measure: Number of Days Without Mechanical Ventilation
time frame: Up to 28 days
description: Mechanical ventilation-free days
measure: Days Without Dialysis
time frame: Up to 28 days
description: Dialysis-free days
measure: Hospital Days Not in ICU
time frame: Up to 28 days
description: ICU free days
measure: Days Spent Out of the Hospital
time frame: Up to 28 days
description: Hospital free days
measure: Readmission to ICU
time frame: Up to 28 days
measure: Number of Participants Rehospitalized After Discharge
time frame: Up to 28 days
measure: Length of ICU Stay
time frame: Up to 28 days
measure: Length of Hospital Stay
time frame: Up to 28 days
measure: 28-day Mortality
time frame: Up to 28 days
measure: Location of Death
time frame: Up to 28 days
measure: Cause of Death
time frame: Up to 28 days
measure: Mean Troponin-I
time frame: Up to 28 days
description: From chart review (if available)
measure: CK-MB
time frame: Up to 28 days
description: From chart review (if available)
measure: Creatinine Kinase (CK)
time frame: Up to 28 days
description: From chart review (if available)
measure: Number of Participants Receiving Non-study Vasopressors
time frame: Up to 28 days
measure: Amount of Time Non-study Vasopressors Used
time frame: Up to 28 days
measure: Mean Blood Pressure (Maximum and Minimum)
time frame: Up to 28 days
measure: Mean Central Venous Pressure
time frame: Up to 28 days
measure: Mean Metabolic Panel Laboratory Values
time frame: Up to 28 days
description: From chart review (if available)
measure: Mean Central Venous Oxygen Saturation
time frame: Up to 28 days
description: From chart review (if available)
measure: Anti-hypertensive Agents Used
time frame: Up to 28 days
measure: Diuretic Agents Used
time frame: Up to 28 days
measure: Inotropes Used
time frame: Up to 28 days
arm group label: Phenylephrine
arm group type: Active Comparator
description: Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock
arm group label: Norepinephrine
arm group type: Active Comparator
description: Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock
intervention type: Drug
intervention name: Phenylephrine
description: Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock
arm group label: Phenylephrine
other name: Neosynephrine
intervention type: Drug
intervention name: Norepinephrine
description: Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock
arm group label: Norepinephrine
other name: Levophed
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raj Keriwala, MD, MPH
role: Principal Investigator
affiliation: Vanderbilt University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Arrhythmias, Cardiac
mesh term: Tachycardia
mesh term: Shock
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Norepinephrine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was terminated early due to slow enrollment, lack of support and equipoise. PI left Vanderbilt and the record was completed with data recorded in REDCap.
point of contact: 