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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.

Two very sophisticated trials were designed to test a survival advantage of an open lung strategy for patients receiving mechanical ventilation.^3-4 Although based on sound physiological reasoning and preclinical data, both studies failed to find a benefit. An accompanying . . . [Full Text of this Article]

J. G. Zijlstra, MD, PhD
j.g.zijlstra@int.umcg.nl

J. J. M. Ligtenberg, MD, PhD
University Medical Center Groningen
Groningen, the Netherlands

A. R. J. Girbes, MD, PhD
Free University Medical Center
Amsterdam, the Netherlands

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