Rapid Administration of Carnitine in sEpsis



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:2/16/2018
Start Date:January 2013
End Date:February 2019

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Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock

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.


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
We found this trial at
14
sites
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Rob Sherwin, MD
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Michael Kurz, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Mike Runyon, MD
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Charlotte, NC
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Jeffrey Kline, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Alan Jones, MD
Phone: 601-984-5443
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Boston, Massachusetts 02215
Principal Investigator: Nathan Shapiro, MD
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Boston, MA
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BWH
Boston, Massachusetts
Principal Investigator: Peter Hou
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MGH
Boston, Massachusetts 02114
Principal Investigator: Michael Filbin
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Boston, MA
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Stephen Trzeciak, MD
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Mark Courtney, MD
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Chicago, IL
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Jacksonville, Florida 32209
Principal Investigator: Faheem Gurgis, MD
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Sacramento, California
Principal Investigator: Jason Adams, MD
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Wilmington, Delaware 19803
Principal Investigator: Ryan Arnold, MD
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Wilmington, DE
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Worcester, Massachusetts 01608
Principal Investigator: Nathan Shapiro
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Worcester, MA
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