A double-blind placebo-controlled study to evaluate the safety and efficacy of L-2-oxothiazolidine-4-carboxylic acid in the treatment of patients with acute respiratory distress syndrome*

Objective: Acute respiratory distress syndrome is an abrupt inflammatory illness that involves damage from reactive oxygen species. We examined the efficacy and safety of oxothiazolidine-4-carboxylic acid (OTZ), a free radical scavenger, in treating acute respiratory distress syndrome. Design: Double-blind, placebo-controlled trial. Setting: Multicentered study. Patients: Patients with a Pa0 2 /FiO 2 ≤200 and bilateral infiltrates on chest radiograph, and requiring mechanical ventilation. Interventions: We randomized 215 patients to receive OTZ, 210 mg/kg per day every 8 hrs for 14 days or placebo. Measurements and Main Results: Ventilator-free days (the number of days alive and free from ventilator requirement) during the first 30 days of study were 8.3 vs. 13.5 days for the OTZ and placebo groups, respectively (p