Open randomized phase II trial of an extracorporeal endotoxin adsorber in suspected Gram-negative sepsis.

Objective: An initial phase II trial to investigate the safety and therapeutic effect of the endotoxin adsorber system EN 500 in septic patients suffering from presumed Gram-negative infection.

Design: Open, controlled, prospective, randomized, multiple-center, parallel-group clinical trial.

Setting: Intensive care units of 31 university-affiliated and community hospitals in Europe.

Multiple-center, randomized, placebo-controlled, double-blind study of the nitric oxide synthase inhibitor 546C88: effect on survival in patients with septic shock.

Objective: To assess the safety and efficacy of the nitric oxide synthase inhibitor 546C88 in patients with septic shock. The predefined primary efficacy objective was survival at day 28.

Design: Multiple-center, randomized, two-stage, double-blind, placebo-controlled, safety and efficacy study.

A pilot study to investigate the effects of an infusion of aminophylline on renal function following major abdominal surgery.

Acute renal failure is a frequent complication of critical illness and optimal preventive therapy remains elusive. There is increasing evidence from animal models and some human studies that adenosine receptor antagonism by aminophylline may reduce the severity of renal impairment caused by a variety of aetiologies. We studied the renal effects of intravenous aminophylline in an unblinded, within-patient study of 20 patients admitted to a general intensive care unit following major surgery.