Critical Care Medicine

The prospective, randomized, double-blind, placebo-controlled clinical trial remains quintessential in resolving often complex, controversial clinical problems. Its importance is epitomized in the resolution of the decades-old debate over the role of corticosteroids in septic shock and in the adult respiratory distress syndrome (ARDS). Corticosteroids do not help, and they may hurt.

The Veterans Administration Systemic Sepsis Cooperative Study Group¹ randomized patients with clinical signs of sepsis and a normal sensorium to receive methylprednisolone sodium succinate (30 mg/kg by intravenous bolus and then 5 mg/kg per hour for 9 hours) or placebo. One hundred twelve patients received the study drug and 111 served as controls. The average time between the diagnosis of sepsis and infusion was 2.8 hours. At 14 days, there was no difference in the main end point of mortality rates, which were 21% for the methylprednisolone group and 22% for the placebo group; nor was there any