A double-blind, prospective, randomized trial of ketoconazole, a thromboxane synthetase inhibitor, in the prophylaxis of the adult respiratory distress syndrome

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Abstract
To determine if ketoconazole, a thromboxane A2 synthetase inhibitor, given within the first 24 hrs after diagnosis and arrival in the intensive care unit (ICU) would decrease the frequency of adult respiratory distress syndrome in the septic patient population. Prospective, randomized, double-blind, placeocontrolled study. Twelve-bed, surgical ICU in a university-affiliated hospital. Fifty-four consecutive patients admitted to the surgical ICU with the diagnosis of sepsis composed the study sample. Sepsis was defined as including two or more of the following signs in a patient with a systolic blood pressure of 12,000 leukocytes, or ≤4000 leukocytes/μL, or ≥20% immature cells; c) positive blood culture; d) known or strongly suspected source of infection from which a known pathogen was cultured. Patients were randomized to receive either ketoconazole (400 mg) or placebo in a double-blind fashion as early as possible and in Measurements and Main Results: Adult respiratory distress syndrome (ARDS) was diagnosed if the following criteria were met: a) intrapulmonary shunt of >20%, or a PaO2/Fio2 ratio of 48 hrs; b) pulmonary artery occlusion pressure of Conclusions: Ketoconazole (400 mg through the gastrointestinal tract) given early in the septic course may prevent ARDS and decrease the mortality rate in high-risk, septic patients. (Crit Care Med 1993; 21:1635–1642)

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