NHLBI ARDS Network

Ketoconzole and Respiratory Management in Acute Lung Injury and Adult Respiratory Distress Syndrome

This study was a randomized, controlled multi-center 2 x 2 factorial study. Each patient was randomized to either the 12 ml/kg ventilation or 6 ml/kg ventilation treatment group and between Ketoconazole and Placebo. Ketoconazole is a synthetic imidazole derivative approved for use as an anti-fungal. Ketoconazole also has immunomodulatory properties and two small studies suggested efficacy in ARDS prevention. This study was designed to test whether the administration of ketoconazole early after the onset of ALI or ARDS would reduce mortality and morbidity. 234 patients were enrolled in this arm of the study before it was stopped by the Data and Safety Monitoring Board for lack of efficacy. The results of this study were published in April 2000(The ARDS Network Authors for the ARDS Network. Ketoconazole for early treatment of Acute Lung Injury and Acute Respiratory Distress Syndrome. A randomized controlled trial. JAMA, 2000;283:1995-2002).