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Rapid Administration of Carnitine in sEpsis (RACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Mississippi Medical Center
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Alan Jones, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01665092
First received: August 11, 2012
Last updated: May 10, 2016
Last verified: May 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Mississippi Medical Center:

Primary Outcome Measures:
  • delta SOFA [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Henry Wang, MD         
Principal Investigator: Henry Wang, MD         
United States, California
Univeristy of California Davis Recruiting
Sacramento, California, United States
Contact: James Holmes, MD         
Principal Investigator: James Holmes, 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 Recruiting
Chicago, Illinois, United States
Contact: Mark Courtney, MD         
Principal Investigator: Mark Courtney, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States
Contact: Jeffrey Kline, MD         
Principal Investigator: Jeffrey Kline, MD         
United States, Massachusetts
BIDMC Recruiting
Boston, Massachusetts, United States
Contact: Nathan Shapiro, MD         
Principal Investigator: Nathan Shapiro, MD         
BWH Recruiting
Boston, Massachusetts, United States
Principal Investigator: Peter Hou         
MGH Recruiting
Boston, Massachusetts, United States
Principal Investigator: Michael Filbin         
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 
Study First Received: August 11, 2012
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 23, 2016