<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/NCT01665092</url>
  </required_header>
  <id_info>
    <org_study_id>GM103799</org_study_id>
    <nct_id>NCT01665092</nct_id>
  </id_info>
  <brief_title>Rapid Administration of Carnitine in sEpsis</brief_title>
  <acronym>RACE</acronym>
  <official_title>Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Mississippi Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate&#xD;
      oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling&#xD;
      and cardiac mechanical efficiency. The overall goal of this proposal is to investigate&#xD;
      L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators&#xD;
      will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor&#xD;
      dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an&#xD;
      associated decrease in 28-day mortality suggesting the need for further phase III study. To&#xD;
      accomplish this the investigators will conduct a phase II, double blinded, placebo&#xD;
      controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent&#xD;
      septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or&#xD;
      high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early&#xD;
      resuscitative care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Delta SOFA Score</measure>
    <time_frame>48 hours</time_frame>
    <description>Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carnitine Low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Levo-Carnitine 6g</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carnitine Medium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Levo-Carnitine 12 g</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carnitine High</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Levo-Carnitine 18 g</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levo-Carnitine</intervention_name>
    <arm_group_label>Carnitine High</arm_group_label>
    <arm_group_label>Carnitine Low</arm_group_label>
    <arm_group_label>Carnitine Medium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Suspected or confirmed infection (examples include but are not limited to: white cells&#xD;
             in a normally sterile body fluid; perforated viscus; radiographic evidence of&#xD;
             pneumonia in clinical symptoms; a syndrome associated with a high risk of infection&#xD;
             e.g. cellulitis, cutaneous abscess, ascending cholangitis, toxic shock syndrome, fever&#xD;
             of unknown origin with high suspicion of infectious etiology)&#xD;
&#xD;
          2. Any two of four criteria of systemic inflammatory response as defined by the 2001&#xD;
             ACCP/SCCM Consensus Conference Committee;&#xD;
&#xD;
          3. Recognition of septic shock and initiation of quantitative resuscitation within 24&#xD;
             hours of enrollment;&#xD;
&#xD;
          4. Requirement of high dose vasopressors for ≥4 hours to treat shock: Norepinephrine &gt;&#xD;
             0.05mcg/kg/min; dopamine &gt;10mcg/kg/min; Phenylephrine &gt;0.4 mcg/kg/min; epinephrine &gt;&#xD;
             0.05 mcg/kg/min;&#xD;
&#xD;
          5. Cumulative sequential organ failure assessment (SOFA) score of ≥ 6;&#xD;
&#xD;
          6. Blood lactate level of &gt;2.0 mMol/L.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18 years;&#xD;
&#xD;
          2. Pregnancy or breastfeeding;&#xD;
&#xD;
          3. Any primary diagnosis other than sepsis;&#xD;
&#xD;
          4. Established Do Not Resuscitate status or advanced directives restricting aggressive&#xD;
             care or treating physician deems aggressive care unsuitable;&#xD;
&#xD;
          5. Any history of seizures or a known seizure disorder;&#xD;
&#xD;
          6. Any known inborn error of metabolism;&#xD;
&#xD;
          7. Anticipated requirement for surgery that would interfere with the 12 hour infusion&#xD;
             time;&#xD;
&#xD;
          8. Active participation in another interventional study;&#xD;
&#xD;
          9. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to&#xD;
             enrollment;&#xD;
&#xD;
         10. Known systemic allergy to L-carnitine.&#xD;
&#xD;
         11. Severe immunocompromised state (e.g. subject has neutropenia [receiving cytotoxic&#xD;
             chemotherapy with absolute neutrophil count &lt;500/uL or expected to decline to &lt; 500 uL&#xD;
             within the next three days).&#xD;
&#xD;
         12. Active Treatment with Coumadin&#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>Alan Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</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>Univeristy of California Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health Services</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BIDMC</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BWH</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MGH</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Hospital</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>29316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 11, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>April 23, 2019</results_first_submitted>
  <results_first_submitted_qc>May 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2019</results_first_posted>
  <last_update_submitted>May 16, 2019</last_update_submitted>
  <last_update_submitted_qc>May 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mississippi Medical Center</investigator_affiliation>
    <investigator_full_name>Alan Jones</investigator_full_name>
    <investigator_title>Professor of Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT01665092/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Normal saline&#xD;
placebo</description>
        </group>
        <group group_id="P2">
          <title>Carnitine Low</title>
          <description>Levo-Carnitine 6g&#xD;
Levo-Carnitine</description>
        </group>
        <group group_id="P3">
          <title>Carnitine Medium</title>
          <description>Levo-Carnitine 12 g&#xD;
Levo-Carnitine</description>
        </group>
        <group group_id="P4">
          <title>Carnitine High</title>
          <description>Levo-Carnitine 18 g&#xD;
Levo-Carnitine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Normal saline&#xD;
placebo</description>
        </group>
        <group group_id="B2">
          <title>Carnitine Low</title>
          <description>Levo-Carnitine 6g&#xD;
Levo-Carnitine</description>
        </group>
        <group group_id="B3">
          <title>Carnitine Medium</title>
          <description>Levo-Carnitine 12 g&#xD;
Levo-Carnitine</description>
        </group>
        <group group_id="B4">
          <title>Carnitine High</title>
          <description>Levo-Carnitine 18 g&#xD;
Levo-Carnitine</description>
        </group>
        <group group_id="B5">
          <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="75"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="34"/>
            <count group_id="B4" value="106"/>
            <count group_id="B5" value="250"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.22" spread="16.5"/>
                    <measurement group_id="B2" value="67.51" spread="12.01"/>
                    <measurement group_id="B3" value="64.91" spread="12.56"/>
                    <measurement group_id="B4" value="59.67" spread="14.50"/>
                    <measurement group_id="B5" value="62" spread="14"/>
                  </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="36"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="64"/>
                    <measurement group_id="B5" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="100"/>
                    <measurement group_id="B5" value="238"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="106"/>
                    <measurement group_id="B5" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Delta SOFA Score</title>
        <description>Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Normal saline&#xD;
placebo</description>
          </group>
          <group group_id="O2">
            <title>Carnitine Low</title>
            <description>Levo-Carnitine 6g&#xD;
Levo-Carnitine</description>
          </group>
          <group group_id="O3">
            <title>Carnitine Medium</title>
            <description>Levo-Carnitine 12 g&#xD;
Levo-Carnitine</description>
          </group>
          <group group_id="O4">
            <title>Carnitine High</title>
            <description>Levo-Carnitine 18 g&#xD;
Levo-Carnitine</description>
          </group>
        </group_list>
        <measure>
          <title>Delta SOFA Score</title>
          <description>Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="34"/>
                <count group_id="O4" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.35"/>
                    <measurement group_id="O2" value="-0.34" spread="0.66"/>
                    <measurement group_id="O3" value="-1.68" spread="0.61"/>
                    <measurement group_id="O4" value="-2.15" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Normal saline&#xD;
placebo</description>
        </group>
        <group group_id="E2">
          <title>Carnitine Low</title>
          <description>Levo-Carnitine 6g&#xD;
Levo-Carnitine</description>
        </group>
        <group group_id="E3">
          <title>Carnitine Medium</title>
          <description>Levo-Carnitine 12 g&#xD;
Levo-Carnitine</description>
        </group>
        <group group_id="E4">
          <title>Carnitine High</title>
          <description>Levo-Carnitine 18 g&#xD;
Levo-Carnitine</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="34" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="45" subjects_at_risk="106"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="106"/>
              </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="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="106"/>
              </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 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>Alan Jones</name_or_title>
      <organization>Univeristy of Mississippi Medical Center</organization>
      <phone>601-384-5586</phone>
      <email>aejones@umc.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/NCT01665092
org study id: GM103799
nct id: NCT01665092
lead sponsor: 
collaborator: 
has dmc: Yes
Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate
      oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling
      and cardiac mechanical efficiency. The overall goal of this proposal is to investigate
      L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators
      will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor
      dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an
      associated decrease in 28-day mortality suggesting the need for further phase III study. To
      accomplish this the investigators will conduct a phase II, double blinded, placebo
      controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent
      septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or
      high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early
      resuscitative care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Delta SOFA Score
time frame: 48 hours
description: Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.
arm group label: Control
arm group type: Placebo Comparator
description: Normal saline
arm group label: Carnitine Low
arm group type: Experimental
description: Levo-Carnitine 6g
arm group label: Carnitine Medium
arm group type: Experimental
description: Levo-Carnitine 12 g
arm group label: Carnitine High
arm group type: Experimental
description: Levo-Carnitine 18 g
intervention type: Drug
intervention name: Levo-Carnitine
arm group label: Carnitine High
arm group label: Carnitine Low
arm group label: Carnitine Medium
intervention type: Drug
intervention name: placebo
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan Jones, MD
role: Principal Investigator
affiliation: University of Mississippi Medical Center
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country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Mississippi Medical Center
investigator full name: Alan Jones
investigator title: Professor of Emergency Medicine
mesh term: Shock, Septic
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 