<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/NCT03026777</url>
  </required_header>
  <id_info>
    <org_study_id>Prepare</org_study_id>
    <nct_id>NCT03026777</nct_id>
  </id_info>
  <brief_title>Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation</brief_title>
  <acronym>PrePARE</acronym>
  <official_title>Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation: The PrePARE Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louisiana State University Health Sciences Center in New Orleans</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endotracheal intubation is common in the care of critically ill patients. Complications of&#xD;
      airway management in this setting are frequently encountered and may be associated with an&#xD;
      increased risk of death. The prevention of complications during urgent and emergent&#xD;
      endotracheal intubation is a key focus for airway management research. Post-intubation&#xD;
      hypotension (PIH), a common complication of endotracheal intubation in the critically ill,&#xD;
      may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but&#xD;
      this approach has not been examined in a prospective trial. There are no randomized trials of&#xD;
      intravenous fluid administration to prevent PIH in critically ill adults. The investigators&#xD;
      propose a randomized trial of fluid loading to prevent PIH in critically ill adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a randomized, parallel-group trial evaluating the impact of fluid&#xD;
      loading to decrease cardiovascular collapse during and after endotracheal intubation in&#xD;
      critically ill adults. Patients admitted to the study sites who are deemed by their clinical&#xD;
      team to require intubation and fulfill inclusion criteria without meeting exclusion criteria&#xD;
      will be enrolled and randomly assigned to intravenous fluid loading versus none. All other&#xD;
      decisions regarding airway management will remain at the discretion of the treating provider.&#xD;
      Data will be collected at the time of intubation and prospectively from the medical record in&#xD;
      order to determine the effect of the assigned intervention on short- and long-term outcomes.&#xD;
      All data are collected non-invasively and are already a part of clinical data obtained in&#xD;
      usual ICU care at the bedside or in the medical record. No additional data will be collected&#xD;
      that is not observed at the bedside or obtained from the medical record.&#xD;
&#xD;
      Study Population: The study population will be all critically ill adults for whom the&#xD;
      clinical team has decided to perform endotracheal intubation using sedation with or without&#xD;
      neuromuscular blockade. Patients will be excluded only if the operator feels: 1. Additional&#xD;
      intravenous fluids in the form of fluid loading is absolutely indicated or contraindicated,&#xD;
      or 2. The urgency of the intubation would make performing the study procedures unsafe.&#xD;
      Patients will be included regardless of gender, race, weight or body mass index, initial&#xD;
      oxygen saturation, anticipated grade of view, and other clinical factors.&#xD;
&#xD;
      Study Interventions:&#xD;
&#xD;
      Fluid Loading - (1) 500 milliliters of an intravenous crystalloid solution of the operator's&#xD;
      choosing will be (2) infused at any time after randomization and prior to the administration&#xD;
      of procedural medications from (3) above the level of the central or peripheral intravenous&#xD;
      or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have&#xD;
      infused. All intravenous infusions preceding the decision to perform endotracheal intubation&#xD;
      will not be altered.&#xD;
&#xD;
      No Fluid Loading - No intravenous fluids are started after the decision is made to perform&#xD;
      endotracheal intubation. All intravenous infusions preceding the decision to perform&#xD;
      endotracheal intubation will not be altered.&#xD;
&#xD;
      Primary Endpoint:&#xD;
&#xD;
      Cardiovascular collapse - a composite endpoint defined as one or more of the following:&#xD;
&#xD;
        -  Death within 1 hour of intubation&#xD;
&#xD;
        -  Cardiac arrest within 1 hour of intubation&#xD;
&#xD;
        -  New systolic blood pressure &lt; 65 mmHg between induction and 2 minutes after completion&#xD;
           of intubation&#xD;
&#xD;
        -  New or increased vasopressor receipt between induction and 2 minutes after completion of&#xD;
           intubation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Cardiovascular Collapse</measure>
    <time_frame>1 hour</time_frame>
    <description>a composite endpoint defined as one or more of the following:&#xD;
Death within 1 hour of intubation&#xD;
Cardiac arrest within 1 hour of intubation&#xD;
New systolic blood pressure &lt; 65 mmHg between induction and 2 minutes after completion of intubation&#xD;
New or increased vasopressor receipt between induction and 2 minutes after completion of intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital Mortality</measure>
    <time_frame>from date of randomization through study completion, an average of 28 days</time_frame>
    <description>What was the patient's vital status at the time of hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free Days</measure>
    <time_frame>from date of randomization through study completion, an average of 28 days</time_frame>
    <description>Number of days alive and free of invasive ventilation in a 28-day period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU-free Days</measure>
    <time_frame>from date of randomization through study completion, an average of 28 days</time_frame>
    <description>Number of days alive and outside of an ICU in a 28 day period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest Arterial Oxygen Saturation</measure>
    <time_frame>between induction and 2 minutes following procedure</time_frame>
    <description>Lowest arterial oxygen saturation between induction and 2 min after intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Laryngoscopy Attempts</measure>
    <time_frame>during procedure</time_frame>
    <description>Number of laryngoscopy attempts to achieve successful tracheal intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lowest Systolic Blood Pressure</measure>
    <time_frame>between induction and 2 minutes following procedure</time_frame>
    <description>Lowest systolic blood pressure between induction and 2 min after intubation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">337</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>Fluid Loading</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intravenous crystalloid fluid, 500 mL</intervention_name>
    <arm_group_label>Fluid Loading</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is admitted to participating study unit&#xD;
&#xD;
          -  Planned procedure is endotracheal intubation and planned operator is a provider&#xD;
             expected to routinely perform endotracheal intubation in the participating unit&#xD;
&#xD;
          -  Administration of sedation with or without neuromuscular blockade is planned&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Operator believes fluid loading to be absolutely indicated or contraindicated for the&#xD;
             safe care of the patient&#xD;
&#xD;
          -  Urgency of intubation precludes safe performance of study procedures&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Age &lt; 18 years old&#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>David Janz, MD, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>LSU School of Medicine New Orleans</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>Jefferson</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSUHSC and University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincoln Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>November 13, 2020</results_first_submitted>
  <results_first_submitted_qc>December 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 5, 2021</results_first_posted>
  <last_update_submitted>December 8, 2020</last_update_submitted>
  <last_update_submitted_qc>December 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center in New Orleans</investigator_affiliation>
    <investigator_full_name>David Janz</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03026777/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03026777/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fluid Loading</title>
          <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="168"/>
                <participants group_id="P2" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="168"/>
                <participants group_id="P2" count="169"/>
              </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>
      <population>All patients randomized were included in the baseline analysis</population>
      <group_list>
        <group group_id="B1">
          <title>Fluid Loading</title>
          <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</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="168"/>
            <count group_id="B2" value="169"/>
            <count group_id="B3" value="337"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" lower_limit="47" upper_limit="70"/>
                    <measurement group_id="B2" value="58" lower_limit="46" upper_limit="68"/>
                    <measurement group_id="B3" value="60" lower_limit="49" upper_limit="69"/>
                  </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="81"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White Race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="101"/>
                  </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="168"/>
                    <measurement group_id="B2" value="169"/>
                    <measurement group_id="B3" value="337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body-mass index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27" lower_limit="14" upper_limit="27"/>
                    <measurement group_id="B2" value="26" lower_limit="22" upper_limit="32"/>
                    <measurement group_id="B3" value="26" lower_limit="22" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Acute physiology and chronic health evaluation score</title>
          <description>range 0 to 71, higher scores indicate a higher severity of illness</description>
          <units>units on a scale, range 0 to 71</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21" lower_limit="14" upper_limit="27"/>
                    <measurement group_id="B2" value="20" lower_limit="16" upper_limit="27"/>
                    <measurement group_id="B3" value="20" lower_limit="16" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Cardiovascular Collapse</title>
        <description>a composite endpoint defined as one or more of the following:&#xD;
Death within 1 hour of intubation&#xD;
Cardiac arrest within 1 hour of intubation&#xD;
New systolic blood pressure &lt; 65 mmHg between induction and 2 minutes after completion of intubation&#xD;
New or increased vasopressor receipt between induction and 2 minutes after completion of intubation</description>
        <time_frame>1 hour</time_frame>
        <population>All patients randomized were included in the primary analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Fluid Loading</title>
            <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cardiovascular Collapse</title>
          <description>a composite endpoint defined as one or more of the following:&#xD;
Death within 1 hour of intubation&#xD;
Cardiac arrest within 1 hour of intubation&#xD;
New systolic blood pressure &lt; 65 mmHg between induction and 2 minutes after completion of intubation&#xD;
New or increased vasopressor receipt between induction and 2 minutes after completion of intubation</description>
          <population>All patients randomized were included in the primary analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In-hospital Mortality</title>
        <description>What was the patient's vital status at the time of hospital discharge</description>
        <time_frame>from date of randomization through study completion, an average of 28 days</time_frame>
        <population>intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Fluid Loading</title>
            <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
          </group>
        </group_list>
        <measure>
          <title>In-hospital Mortality</title>
          <description>What was the patient's vital status at the time of hospital discharge</description>
          <population>intention to treat</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilator-free Days</title>
        <description>Number of days alive and free of invasive ventilation in a 28-day period</description>
        <time_frame>from date of randomization through study completion, an average of 28 days</time_frame>
        <population>intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Fluid Loading</title>
            <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilator-free Days</title>
          <description>Number of days alive and free of invasive ventilation in a 28-day period</description>
          <population>intention to treat</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="0" upper_limit="25"/>
                    <measurement group_id="O2" value="19" lower_limit="0" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ICU-free Days</title>
        <description>Number of days alive and outside of an ICU in a 28 day period</description>
        <time_frame>from date of randomization through study completion, an average of 28 days</time_frame>
        <population>intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Fluid Loading</title>
            <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
          </group>
        </group_list>
        <measure>
          <title>ICU-free Days</title>
          <description>Number of days alive and outside of an ICU in a 28 day period</description>
          <population>intention to treat</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="0" upper_limit="24"/>
                    <measurement group_id="O2" value="14" lower_limit="0" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lowest Arterial Oxygen Saturation</title>
        <description>Lowest arterial oxygen saturation between induction and 2 min after intubation</description>
        <time_frame>between induction and 2 minutes following procedure</time_frame>
        <population>intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Fluid Loading</title>
            <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
          </group>
        </group_list>
        <measure>
          <title>Lowest Arterial Oxygen Saturation</title>
          <description>Lowest arterial oxygen saturation between induction and 2 min after intubation</description>
          <population>intention to treat</population>
          <units>percentage of hemoglobin</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="84" upper_limit="99"/>
                    <measurement group_id="O2" value="95" lower_limit="82" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Laryngoscopy Attempts</title>
        <description>Number of laryngoscopy attempts to achieve successful tracheal intubation</description>
        <time_frame>during procedure</time_frame>
        <population>intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Fluid Loading</title>
            <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Laryngoscopy Attempts</title>
          <description>Number of laryngoscopy attempts to achieve successful tracheal intubation</description>
          <population>intention to treat</population>
          <units>attempts</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lowest Systolic Blood Pressure</title>
        <description>Lowest systolic blood pressure between induction and 2 min after intubation</description>
        <time_frame>between induction and 2 minutes following procedure</time_frame>
        <population>intention to treat</population>
        <group_list>
          <group group_id="O1">
            <title>Fluid Loading</title>
            <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</description>
          </group>
        </group_list>
        <measure>
          <title>Lowest Systolic Blood Pressure</title>
          <description>Lowest systolic blood pressure between induction and 2 min after intubation</description>
          <population>intention to treat</population>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119" lower_limit="95" upper_limit="140"/>
                    <measurement group_id="O2" value="119" lower_limit="94" upper_limit="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days after enrollment and randomization</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fluid Loading</title>
          <description>(1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.&#xD;
intravenous crystalloid fluid, 500 mL</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.</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="48" subjects_at_risk="168"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="168"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </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="168"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Dr. David Janz</name_or_title>
      <organization>LSUHSC New Orleans</organization>
      <phone>504-913-5006</phone>
      <email>djanz@lsuhsc.edu</email>
    </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/NCT03026777
org study id: Prepare
nct id: NCT03026777
lead sponsor: 
has dmc: Yes
Endotracheal intubation is common in the care of critically ill patients. Complications of
      airway management in this setting are frequently encountered and may be associated with an
      increased risk of death. The prevention of complications during urgent and emergent
      endotracheal intubation is a key focus for airway management research. Post-intubation
      hypotension (PIH), a common complication of endotracheal intubation in the critically ill,
      may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but
      this approach has not been examined in a prospective trial. There are no randomized trials of
      intravenous fluid administration to prevent PIH in critically ill adults. The investigators
      propose a randomized trial of fluid loading to prevent PIH in critically ill adults.
The investigators propose a randomized, parallel-group trial evaluating the impact of fluid
      loading to decrease cardiovascular collapse during and after endotracheal intubation in
      critically ill adults. Patients admitted to the study sites who are deemed by their clinical
      team to require intubation and fulfill inclusion criteria without meeting exclusion criteria
      will be enrolled and randomly assigned to intravenous fluid loading versus none. All other
      decisions regarding airway management will remain at the discretion of the treating provider.
      Data will be collected at the time of intubation and prospectively from the medical record in
      order to determine the effect of the assigned intervention on short- and long-term outcomes.
      All data are collected non-invasively and are already a part of clinical data obtained in
      usual ICU care at the bedside or in the medical record. No additional data will be collected
      that is not observed at the bedside or obtained from the medical record.

      Study Population: The study population will be all critically ill adults for whom the
      clinical team has decided to perform endotracheal intubation using sedation with or without
      neuromuscular blockade. Patients will be excluded only if the operator feels: 1. Additional
      intravenous fluids in the form of fluid loading is absolutely indicated or contraindicated,
      or 2. The urgency of the intubation would make performing the study procedures unsafe.
      Patients will be included regardless of gender, race, weight or body mass index, initial
      oxygen saturation, anticipated grade of view, and other clinical factors.

      Study Interventions:

      Fluid Loading - (1) 500 milliliters of an intravenous crystalloid solution of the operator's
      choosing will be (2) infused at any time after randomization and prior to the administration
      of procedural medications from (3) above the level of the central or peripheral intravenous
      or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have
      infused. All intravenous infusions preceding the decision to perform endotracheal intubation
      will not be altered.

      No Fluid Loading - No intravenous fluids are started after the decision is made to perform
      endotracheal intubation. All intravenous infusions preceding the decision to perform
      endotracheal intubation will not be altered.

      Primary Endpoint:

      Cardiovascular collapse - a composite endpoint defined as one or more of the following:

        -  Death within 1 hour of intubation

        -  Cardiac arrest within 1 hour of intubation

        -  New systolic blood pressure < 65 mmHg between induction and 2 minutes after completion
           of intubation

        -  New or increased vasopressor receipt between induction and 2 minutes after completion of
           intubation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Cardiovascular Collapse
time frame: 1 hour
description: a composite endpoint defined as one or more of the following:
Death within 1 hour of intubation
Cardiac arrest within 1 hour of intubation
New systolic blood pressure < 65 mmHg between induction and 2 minutes after completion of intubation
New or increased vasopressor receipt between induction and 2 minutes after completion of intubation
measure: In-hospital Mortality
time frame: from date of randomization through study completion, an average of 28 days
description: What was the patient's vital status at the time of hospital discharge
measure: Ventilator-free Days
time frame: from date of randomization through study completion, an average of 28 days
description: Number of days alive and free of invasive ventilation in a 28-day period
measure: ICU-free Days
time frame: from date of randomization through study completion, an average of 28 days
description: Number of days alive and outside of an ICU in a 28 day period
measure: Lowest Arterial Oxygen Saturation
time frame: between induction and 2 minutes following procedure
description: Lowest arterial oxygen saturation between induction and 2 min after intubation
measure: Number of Laryngoscopy Attempts
time frame: during procedure
description: Number of laryngoscopy attempts to achieve successful tracheal intubation
measure: Lowest Systolic Blood Pressure
time frame: between induction and 2 minutes following procedure
description: Lowest systolic blood pressure between induction and 2 min after intubation
arm group label: Fluid Loading
arm group type: Experimental
description: (1) 500 milliliters of an intravenous crystalloid solution of the operator's choosing will be (2) infused at any time after randomization and prior to the administration of procedural medications from (3) above the level of the central or peripheral intravenous or intraosseus access used and allowed to infuse by gravity and (4) stopped after 500 mL have infused. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
arm group label: Usual Care
arm group type: No Intervention
description: No intravenous fluids are started after the decision is made to perform endotracheal intubation. All intravenous infusions preceding the decision to perform endotracheal intubation will not be altered.
intervention type: Drug
intervention name: intravenous crystalloid fluid, 500 mL
arm group label: Fluid Loading
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Janz, MD, MSc
role: Study Chair
affiliation: LSU School of Medicine New Orleans
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center in New Orleans
investigator full name: David Janz
investigator title: Assistant Professor of Medicine
mesh term: Respiratory Insufficiency
mesh term: Shock
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 