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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

Page last updated: August 23, 2015

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