Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients
This prospective, double-blinded study will determine the feasibility of determining the efficacy of a weekly intramuscular injection of nandrolone (an anabolic steroid) in malnourished ICU patients.The data from this study will also enable us to prepare a future grant proposal with a calculated sample size necessary to demonstrate an improvement in clinical outcome.
Drug: Nandrolone (anabolic steroid)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients|
- Nitrogen Balance
- Lean body mass
- serum prealbumin
- length of stay on ventilator, in ICU, in HOSPITAL
- infectious complications
- outcome (mortality)
|Study Start Date:||October 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Patients receive weekly injections of nandrolone
|Drug: Nandrolone (anabolic steroid)|
|Placebo Comparator: Placebo||Drug: Placebo|
Critically ill patients are particularly prone to excessive catabolism using skeletal muscle as the primary substrate as a result of maladaptation to critical illness. Ultimately, critical illness leads to a significant loss of lean body mass (LBM). For example, a 40% loss of LBM is associated with a 100% mortality. Anabolic steroids have been studied and have been shown to improve nutrition in select malnourished patient groups, however, the majority of these studies were not well designed or consisted of small sample sizes.
Our hypothesis is anabolic steroid administration will result in an augmentation of positive nitrogen balance and LBM. This increase in LBM will result in liberation from mechanical ventilation sooner than the placebo group and will result in discharge from the ICU sooner, and as a result, a reduction in morbidity (nosocomial infections) and possibly mortality.
All moderately to severly malnourished ICU patients who have an anticipated stay in ICU > 10 days, will be randomized to receive nandrolone (25 mg-females, 50 mg;males) once weekly for six weeks or placebo. All patients will receive a standard enteral nutritional regimen. Patients will be monitored for assessment of nitrogen balance, lean body mass, and length of time spent on ventilator, in ICU and in HOSP, and incidence of infections.Lean body mass will be measured using a bioimpedance analyzer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242463
|London Health Sciences Centre-UC|
|London, Ontario, Canada, N6A5A5|
|Principal Investigator:||Michael D Sharpe, MD FRCPC||London Health Sciences Centre-UC|