Rapid Administration of Carnitine in sEpsis

Completed · Phase 2 · Has a placebo group

Conditions studied: Septic Shock

In brief

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.

Key facts

Study ID

NCT01665092

Run by

University of Mississippi Medical Center

People needed

250

Starts

2013-01-01

Expected to finish

2019-03-01

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Any two of four criteria of systemic inflammatory response as defined by the 2001 ACCP/SCCM Consensus Conference Committee;
• Recognition of septic shock and initiation of quantitative resuscitation within 24 hours of enrollment;
• 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;
• Cumulative sequential organ failure assessment (SOFA) score of ≥ 6;
• Blood lactate level of >2.0 mMol/L.

You may not qualify if…

• Age <18 years;
• Pregnancy or breastfeeding;
• Any primary diagnosis other than sepsis;
• Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
• Any history of seizures or a known seizure disorder;
• Any known inborn error of metabolism;
• Anticipated requirement for surgery that would interfere with the 12 hour infusion time;
• Active participation in another interventional study;
• Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
• Known systemic allergy to L-carnitine.
• 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).
• Active Treatment with Coumadin

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Univeristy of California Davis — Sacramento, California, United States
• Christiana Care Health Services — Wilmington, Delaware, United States
• University of Florida — Jacksonville, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• BIDMC — Boston, Massachusetts, United States
• BWH — Boston, Massachusetts, United States
• MGH — Boston, Massachusetts, United States
• St. Vincent Hospital — Worcester, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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