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.