NCT01665092

Rapid Administration of Carnitine in sEpsis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Levo-Carnitine
DRUG	placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-03-01
• Completion: 2019-03-01
• First posted: 2012-08-15
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

14 sites across 1 country: United States