Efficacy and safety of a phospholipid emulsion (GR270773) in Gram-negative severe sepsis: Results of a phase II multicenter, randomized, placebo-controlled, dose-finding clinical trial
R Phillip Dellinger, John F Tomayko, Derek C Angus, Steven Opal, Michael A Cupo, Sharon McDermott, Annie Ducher, Thierry Calandra, Jonathan Cohen
CRITICAL CARE MEDICINE | LIPPINCOTT WILLIAMS & WILKINS | Published : 2009
OBJECTIVE: To assess the survival benefit and safety profile of low-dose (850 mg/kg) and high-dose (1350 mg/kg) phospholipid emulsion vs. placebo administered as a continuous 3-day infusion in patients with confirmed or suspected Gram-negative severe sepsis. Preclinical and ex vivo studies show that lipoproteins bind and neutralize endotoxin, and experimental animal studies demonstrate protection from septic death when lipoproteins are administered. Endotoxin neutralization correlates with the amount of phospholipid in the lipoprotein particles. DESIGN: A three-arm, randomized, blinded, placebo-controlled trial. SETTING: Conducted at 235 centers worldwide between September 2004 and April 200..View full abstract
This study was funded, in part, by GIaxoSmithKline (DCA, SO).