Study Objective. To determine the effect of oxandrolone administration on n
utritional 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 comple
ted 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 en
teral nutrition and then at day 7, day 10, and study exit. Patients were as
sessed daily for metabolic and infectious complications. The two groups wer
e similar for demographics and dosage of enteral nutrition. Measurement of
total urinary nitrogen at study entry showed both groups to be highly catab
olic (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 wa
s no significant difference between groups. Nitrogen balance was negative t
hroughout the study in each group. Body cell mass decreased slightly in bot
h groups over the study period. Prealbumin serum concentrations increased s
ignificantly in both groups at day 10 and study exit compared with study en
try. The groups did not differ significantly for length of hospital stay (o
xandrolone 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 f
requency of pneumonia or sepsis (oxandrolone 48, placebo 43 episodes).
Conclusion. Oxandrolone 20 mg/day does not have obvious benefit in nutritio
nal and clinical outcomes during the first month after multiple trauma.