To the Editor: Randomized controlled trials (RCTs) are often considered the highest form of clinical evidence. However, RCTs providing evidence for reduced mortality using a treatment for patients in intensive care units (ICUs) are scarce. The few trials demonstrating survival advantage were incorporated in the Surviving Sepsis Campaign.1 However, even some of these trials have been challenged.2 We are aware of no large RCTs in the ICU setting with beneficial results that have been confirmed by a second RCT. Given that there are also studies with survival disadvantage in the treatment arm,2 it is possible that the outcome of these studies reflects chance: 2.5% negative, 2.5% positive, and 95% no association.
Zijlstra JG, Ligtenberg JJM, Girbes ARJ. Randomized Controlled Trials in Critical Care Medicine. JAMA. 2008;300(1):43-44. doi:10.1001/jama.300.1.43-a