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Rapid Administration of Carnitine in sEpsis (RACE)

This study is currently recruiting participants.
Verified August 2017 by Alan Jones, University of Mississippi Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665092
First Posted: August 15, 2012
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Alan Jones, University of Mississippi Medical Center
  Purpose
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 Intervention Phase
Septic Shock Drug: Levo-Carnitine Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alan Jones, University of Mississippi Medical Center:

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

Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 day ]

Estimated Enrollment: 250
Study Start Date: January 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
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


Contacts
Contact: Alan Jones, MD 601-984-5571 aejones@umc.edu

Locations
United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States
Contact: Michael Kurz, MD         
Principal Investigator: Michael Kurz, MD         
United States, California
Univeristy of California Davis Recruiting
Sacramento, California, United States
Contact: Jason Adams, MD         
Principal Investigator: Jason Adams, MD         
United States, Delaware
Christiana Care Health Services Recruiting
Wilmington, Delaware, United States
Contact: Ryan Aronold, MD         
Principal Investigator: Ryan Arnold, MD         
United States, Florida
University of Florida Recruiting
Jacksonville, Florida, United States
Contact: Faheem Gurgis, MD         
Principal Investigator: Faheem Gurgis, MD         
United States, Illinois
Northwestern University Suspended
Chicago, Illinois, United States
United States, Indiana
Indiana University Suspended
Indianapolis, Indiana, United States
United States, Massachusetts
BIDMC Recruiting
Boston, Massachusetts, United States
Contact: Nathan Shapiro, MD         
Principal Investigator: Nathan Shapiro, MD         
BWH Recruiting
Boston, Massachusetts, United States
Contact: Peter Hou         
Principal Investigator: Peter Hou         
MGH Recruiting
Boston, Massachusetts, United States
Contact: Michael Filbin         
Principal Investigator: Michael Filbin         
St. Vincent Hospital Recruiting
Worcester, Massachusetts, United States
Contact: Nathan Shapiro         
Principal Investigator: Nathan Shapiro         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States
Contact: Rob Sherwin, MD         
Principal Investigator: Rob Sherwin, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 29316
Contact: Alan Jones, MD    601-984-5443    aejones@umc.edu   
Principal Investigator: Alan Jones, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States
Contact: Stephen Trzeciak, MD         
Principal Investigator: Stephen Trzeciak, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States
Contact: Mike Runyon, MD         
Principal Investigator: Mike Runyon, MD         
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
  More Information

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 Submitted: August 11, 2012
First Posted: August 15, 2012
Last Update Posted: August 24, 2017
Last Verified: August 2017
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