Randomized, double-blind, placebo-controlled, multicenter. Recruitment at the seven clinical sites began in October 1989 and ended in March 1995. A total of 224 patients were randomized in a double-blind fashion to ibuprofen given intravenously every six hours for a total of eight doses and 231 patients were randomized to placebo. The major endpoint was mortality rate at 30 days after randomization. Before the first dose of the study drug, a baseline medical history was taken and a physical examination was performed to document the presumed cause, site, and time of onset of the sepsis syndrome. Blood was obtained for culture from at least two sites. Infection was classified as occurring in the lungs, peritoneum, or urinary tract or at another site or an unknown site. Chest radiographs were obtained at entry and scored by the chest radiologist to indicate the presence and severity of pulmonary edema.