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Rapid Administration of Carnitine in sEpsis (RACE)

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ClinicalTrials.gov Identifier: NCT01665092
Recruitment Status : Active, not recruiting
First Posted : August 15, 2012
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Alan Jones, University of Mississippi Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Levo-Carnitine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock
Study Start Date : January 2013
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control
Normal saline
Drug: placebo
Experimental: Carnitine Low
Levo-Carnitine 6g
Drug: Levo-Carnitine
Experimental: Carnitine Medium
Levo-Carnitine 12 g
Drug: Levo-Carnitine
Experimental: Carnitine High
Levo-Carnitine 18 g
Drug: Levo-Carnitine



Primary Outcome Measures :
  1. delta SOFA [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Suspected or confirmed infection (examples include but are not limited to: white cells in a normally sterile body fluid; perforated viscus; radiographic evidence of pneumonia in clinical symptoms; a syndrome associated with a high risk of infection e.g. cellulitis, cutaneous abscess, ascending cholangitis, toxic shock syndrome, fever of unknown origin with high suspicion of infectious etiology)
  2. Any two of four criteria of systemic inflammatory response as defined by the 2001 ACCP/SCCM Consensus Conference Committee;
  3. Recognition of septic shock and initiation of quantitative resuscitation within 24 hours of enrollment;
  4. Requirement of high dose vasopressors for ≥4 hours to treat shock: Norepinephrine > 0.05mcg/kg/min; dopamine >10mcg/kg/min; Phenylephrine >0.4 mcg/kg/min; epinephrine > 0.05 mcg/kg/min;
  5. Cumulative sequential organ failure assessment (SOFA) score of ≥ 6;
  6. Blood lactate level of >2.0 mMol/L.

Exclusion Criteria:

  1. Age <18 years;
  2. Pregnancy or breastfeeding;
  3. Any primary diagnosis other than sepsis;
  4. Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
  5. Any history of seizures or a known seizure disorder;
  6. Any known inborn error of metabolism;
  7. Anticipated requirement for surgery that would interfere with the 12 hour infusion time;
  8. Active participation in another interventional study;
  9. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
  10. Known systemic allergy to L-carnitine.
  11. Severe immunocompromised state (e.g. subject has neutropenia [receiving cytotoxic chemotherapy with absolute neutrophil count <500/uL or expected to decline to < 500 uL within the next three days).
  12. Active Treatment with Coumadin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665092


Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States
United States, California
Univeristy of California Davis
Sacramento, California, United States
United States, Delaware
Christiana Care Health Services
Wilmington, Delaware, United States
United States, Florida
University of Florida
Jacksonville, Florida, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Indiana
Indiana University
Indianapolis, Indiana, United States
United States, Massachusetts
BIDMC
Boston, Massachusetts, United States
BWH
Boston, Massachusetts, United States
MGH
Boston, Massachusetts, United States
St. Vincent Hospital
Worcester, Massachusetts, United States
United States, Michigan
Wayne State University
Detroit, Michigan, United States
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 29316
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States
Sponsors and Collaborators
University of Mississippi Medical Center
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Alan Jones, MD University of Mississippi Medical Center

Responsible Party: Alan Jones, Professor of Emergency Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01665092     History of Changes
Other Study ID Numbers: GM103799
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock