Lessons learned from clinical trials of sepsis

Abstract

The development of novel therapeutic agents with demonstrable clinical efficacy in septic patients has proven to be an elusive goal. Despite a biologically plausible therapeutic rationale, antisepsis drugs have not performed consistently or convincingly in recent clinical trials. A great deal of information has been learned recently about the basic mechanisms and molecular pathophysiology of sepsis. Nonetheless, the optimal patient population, the clinical and laboratory indicators to predict outcome and susceptibility to treatment, and the most appropriate clinical endpoints have yet to be clearly defined. Refinements in clinical trial design may be as important as basic discoveries in molecular biology in the future development of new therapeutic agents in septic shock.