AEROSOLIZED SURFACTANT IN ADULTS WITH SEPSIS-INDUCED ACUTE RESPIRATORY-DISTRESS SYNDROME

Background. Patients with acute respiratory distress syndrome (ARDS) h ave a deficiency of surfactant, Surfactant replacement improves physio logic function in such patients, and preliminary data suggest that it may improve survival. Methods. We conducted a prospective, multicenter , double-blind, randomized, placebo-controlled trial involving 725 pat ients with sepsis-induced ARDS. Patients were stratified according to the risk of death at base line (indicated by their score on the Acute Physiologic and Chronic Health Evaluation [APACHE III] index) and rand omly assigned to receive either continuously administered synthetic su rfactant (13.5 mg of dipalmitoylphosphatidylcholine per milliliter; 36 4 patients) or placebo (0.45 percent saline; 361 patients) in aerosoli zed form for up to five days. Results. The demographic and physiologic characteristics of the two treatment groups were similar at base line , The mean (+/-SD) age was 50+/-17 years in the surfactant group and 5 3+/-18 years in the placebo group, and the mean APACHE III scores at r andomization were 70.4+/-25 and 70.5+/-25, respectively, Hemodynamic m easures, measures of oxygenation, duration of mechanical ventilation, and length of stay in the intensive care unit did not differ significa ntly in the two groups. Survival at 30 days was 60 percent for both gr oups, Survival was similar in the groups when analyzed according to AP ACHE III score, cause of death, time of onset and severity of ARDS, pr esence or absence of documented sepsis, underlying disease, whether or not there was a do-not-resuscitate order, and medical center. Increas ed secretions were significantly more frequent in the surfactant group ; the rates of other complications were similar in the two groups. Con clusions. The continuous administration of aerosolized synthetic surfa ctant to patients with sepsis-induced ARDS had no significant effect o n 30-day survival, length of stay in the intensive care unit, duration of mechanical ventilation, or physiologic function. (C) 1996, Massach usetts Medical Society.