6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome

Background: Systemic corticosteroids are considered in patients with an adverse clinical course suffering from conditions like the acute respiratory distress syndrome (ARDS) and septic shock. Treated patients not only show improved respiratory function, but also hemodynamic status and overall multiple organ dysfunction score. Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical course of multiple organ dysfunction syndrome (MODS). Design: Multi-center, double-blind, randomized, placebo-controlled. Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous solution). The duration of the study medication administration protocol is 32 days (1). Primary Endpoints: 1. All cause Intensive Care Unit (ICU) and 28-day mortality 2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.