ARDS - SAILS Protocol

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The purpose of the Statins for Acutely Injured Lungs from Sepsis (SAILS) protocol is to assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI). Up to 1000 patients with ALI will be randomized in the study design. The first study drug dose (rosuvastatin or placebo) is 40 mg. Subsequent doses of 20 mg will be administered daily until 28 days after randomization or three days after ICU discharge (whichever occurs first), or discharge from study hospital. The study hypothesis is that the Rosuvastatin will reduce mortality The primary efficacy variable is mortality to study day 60.