First do no harm surrogate endpoints and the lesson of β-agonists in acute lung injury.docVIP

Lakshminarayana and Kahn Critical Care 2012,16:314 /content/16/3/314 JOURNAL CLUB CRITIQUE First do no harm: surrogate endpoints and the lesson of β-agonists in acute lung injury Pradeep H Lakshminarayana and Jeremy M Kahn* 1 1,2,3 University of Pittsburgh Department of Critical Care Medicine: Evidence-Based Medicine Journal Club, edited by Sachin Yende Expanded abstract Citation Outcomes: e primary outcome variable was ventilator- free days (VFD). Secondary outcome measures included mortality before hospital discharge on day 60 and day 90, the number of intensive care unit (ICU)-free days and the number of organ failure-free days. Matthay MA, Brower RG, Carson S, Douglas IS, Eisner M, Hite D, Holets S, Kallet RH, Liu KD, MacIntyre N, Moss M, Schoenfeld D, Steingr ompson BT: Randomized, placebo-controlled clinical trial of an aerosolized β-agonist for treatment of acute lung injury. National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Am J Respir Crit Care Med 2011, 184:561-568. Results ere were 282 patients enrolled before the trial was stopped for futility after the second interim analysis. e VFDs di? erence with albuterol treatment was un- favourable by -2.2 days, well past the futility boundary of -0.4 VFDs. VFDs were not signi? cantly di? erent between Background β -Adrenergic receptor agonists accelerate resolution of the albuterol and placebo groups (means of 14.4 and 2 pulmonary edema in experimental and clinical studies of acute lung injury (ALI). 16.6 days, respectively; 95% con? dence interval for the di? erence, -4.7 to 0.3 days; P = 0.087). Rates of death before hospital discharge and the number of organ failure-free days were also not signi? cantly di? erent Methods Objective: T