Oxandrolone in trauma patients.

STUDY OBJECTIVE To determine the effect of oxandrolone administration on nutritional and clinical outcomes after multiple trauma. DESIGN Prospective, randomized, double-blind, placebo-controlled study. SETTING Level 1 trauma center in a university teaching hospital. PATIENTS Sixty-two patients requiring enteral nutrition, 60 of whom completed the study. INTERVENTION Patients were randomized to receive either oxandrolone 10 mg or placebo twice/day for a maximum of 28 days. MEASUREMENTS AND MAIN RESULTS Total urinary nitrogen, prealbumin, nitrogen balance, total body water, and body cell mass were measured on day 1 of enteral nutrition and then at day 7, day 10, and study exit. Patients were assessed daily for metabolic and infectious complications. The two groups were similar for demographics and dosage of enteral nutrition. Measurement of total urinary nitrogen at study entry showed both groups to be highly catabolic (oxandrolone 17.2 +/- 4.9, placebo 19.1 +/- 10.8 g/day, NS). On days 7 and 10, total urinary nitrogen increased in both groups; however, there was no significant difference between groups. Nitrogen balance was negative throughout the study in each group. Body cell mass decreased slightly in both groups over the study period. Prealbumin serum concentrations increased significantly in both groups at day 10 and study exit compared with study entry. The groups did not differ significantly for length of hospital stay (oxandrolone 30.8 +/- 17.9, placebo 27.0 +/- 25.7 days), length of intensive care unit stay (oxandrolone 17.1 +/- 7.8, placebo 15.5 +/- 9.7 days), and frequency of pneumonia or sepsis (oxandrolone 48, placebo 43 episodes). CONCLUSION Oxandrolone 20 mg/day does not have obvious benefit in nutritional and clinical outcomes during the first month after multiple trauma.