Rapid Administration of Carnitine in sEpsis
Information source: University of Mississippi Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock
Intervention: Levo-Carnitine (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Mississippi Medical Center Official(s) and/or principal investigator(s): Alan Jones, MD, Principal Investigator, Affiliation: University of Mississippi Medical Center
Overall contact: Alan Jones, MD, Phone: 601-984-5571, Email: aejones@umc.edu
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.
Clinical Details
Official title: Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: delta SOFA
Secondary outcome: Mortality
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Alan Jones, MD, Phone: 601-984-5571, Email: aejones@umc.edu
University of Alabama Birmingham, Birmingham, Alabama, United States; Not yet recruiting Henry Wang, MD Henry Wang, MD, Principal Investigator
Univeristy of California Davis, Sacramento, California, United States; Recruiting James Holmes, MD James Holmes, MD, Principal Investigator
Christiana Care Health Services, Wilmington, Delaware, United States; Recruiting Ryan Aronold, MD Ryan Arnold, MD, Principal Investigator
University of Florida, Jacksonville, Florida, United States; Recruiting Faheem Gurgis, MD Faheem Gurgis, MD, Principal Investigator
Northwestern University, Chicago, Illinois, United States; Recruiting Mark Courtney, MD Mark Courtney, MD, Principal Investigator
Indiana University, Indianapolis, Indiana, United States; Recruiting Jeffrey Kline, MD Jeffrey Kline, MD, Principal Investigator
BIDMC, Boston, Massachusetts, United States; Recruiting Nathan Shapiro, MD Nathan Shapiro, MD, Principal Investigator
BWH, Boston, Massachusetts, United States; Recruiting Peter Hou, Principal Investigator
MGH, Boston, Massachusetts, United States; Recruiting Michael Filbin, Principal Investigator
Wayne State University, Detroit, Michigan, United States; Recruiting Rob Sherwin, MD Rob Sherwin, MD, Principal Investigator
University of Mississippi Medical Center, Jackson, Mississippi 29316, United States; Recruiting Alan Jones, MD, Phone: 601-984-5443, Email: aejones@umc.edu Alan Jones, MD, Principal Investigator
Cooper University Hospital, Camden, New Jersey, United States; Recruiting Stephen Trzeciak, MD Stephen Trzeciak, MD, Principal Investigator
Carolinas Medical Center, Charlotte, North Carolina, United States; Recruiting Mike Runyon, MD Mike Runyon, MD, Principal Investigator
Additional Information
Starting date: January 2013
Last updated: June 16, 2015
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