Oxandrolone in trauma patients.
OBJECTIVE
To determine the effect of oxandrolone administration on nutritional and clinical outcomes after multiple trauma.


METHODS
Prospective, randomized, double-blind, placebo-controlled study.


METHODS
Level 1 trauma center in a university teaching hospital.


METHODS
Sixty-two patients requiring enteral nutrition, 60 of whom completed the study.


METHODS
Patients were randomized to receive either oxandrolone 10 mg or placebo twice/day for a maximum of 28 days.


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).


CONCLUSIONS
Oxandrolone 20 mg/day does not have obvious benefit in nutritional and clinical outcomes during the first month after multiple trauma.
Gervasio
J M
JM
Department of Clinical Pharmacy, University of Tennessee-Memphis 38163, USA.
Dickerson
R N
RN
Swearingen
J
J
Yates
M E
ME
Yuen
C
C
Fabian
T C
TC
Croce
M A
MA
Brown
R O
RO
D000328:Adult; D045930:Anabolic Agents / Q000627:therapeutic use*; D000704:Analysis of Variance; D004311:Double-Blind Method; D017097:Electric Impedance; D004573:Electrolytes / Q000097:blood; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D015601:Injury Severity Score; D007902:Length of Stay; D008297:Male; D009104:Multiple Trauma / Q000145:classification / Q000188:drug therapy* / Q000378:metabolism*; D009584:Nitrogen / Q000378:metabolism; D009752:Nutritional Status; D010074:Oxandrolone / Q000627:therapeutic use*; D011446:Prospective Studies; D014193:Trauma Centers
D045930:Anabolic Agents; D004573:Electrolytes; D010074:Oxandrolone; D009584:Nitrogen