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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Mississippi Medical Center
Collaborator:
National Institute of General Medical Sciences (NIGMS)