Oxandrolone does not improve outcome of ventilator dependent surgical patients.
BACKGROUND
Multisystem injury and major surgical stress result in a hypermetabolic state with accelerated breakdown of protein stores. Loss of lean muscle mass impairs wound healing, increases infection rates, and weakens respiratory musculature. Oxandrolone is an anabolic steroid that attenuates loss of lean body mass and improves wound healing in burn patients. We hypothesized that oxandrolone would improve outcome for ventilator-dependent surgical patients.


METHODS
We conducted a randomized, double-blind, placebo-controlled trial of oxandrolone therapy for surgical/trauma patients requiring >7 days of ventilation. The primary end point was time on the ventilator.


RESULTS
Forty-one patients were enrolled between January 1, 2001, and June 15, 2003, 18 received oxandrolone (10 mg po BID) and 23 received a placebo. Groups were comparable for age, gender, injury severity score, and APACHE II score. The majority were trauma patients (83%), and 90% received enteral feeding. The oxandrolone group received higher caloric and protein intake before enrollment, but these differences were not significant. Contrary to our hypothesis, patients receiving oxandrolone spent significantly longer time on the ventilator than the placebo group (mean 21.7 days vs. 16.4 days, P = 0.03). There was no difference in infectious complications, acute respiratory distress syndrome, or multiple organ failure scores. Patients receiving oxandrolone had a longer intensive care unit stay but no difference in total hospital stay.


CONCLUSIONS
Ventilator-dependent surgical patients receiving oxandrolone had a more prolonged course of mechanical ventilation, suggesting that oxandrolone may be detrimental in this circumstance. Oxandrolone may enhance collagen deposition and fibrosis in the later stages of acute respiratory distress syndrome and thus prolong recovery.
Department of Surgery, University of Washington, Seattle 98104, USA. ebulger@u.washington.edu
Eileen M
EM
Bulger
Gregory J
GJ
Jurkovich
Catherine L
CL
Farver
Patricia
P
Klotz
Ronald V
RV
Maier
D018806:APACHE; D000284:Administration, Oral; D045930:Anabolic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003428:Cross Infection / Q000175:diagnosis; D004044:Dietary Proteins / Q000008:administration & dosage; D004311:Double-Blind Method; D002149:Energy Intake; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D015601:Injury Severity Score; D007362:Intensive Care Units; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009104:Multiple Trauma / Q000150:complications / Q000628:therapy*; D010074:Oxandrolone / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012121:Respiration, Artificial
D045930:Anabolic Agents; D004044:Dietary Proteins; D010074:Oxandrolone