Official Title: “The Efficacy of Anabolic Steroids for the 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 deomonstrate an improvement in clinical outcome.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Nandrolone (anabolic steroid)

Primary Measures

• Nitrogen Balance

Secondary Measures

• Lean body mass
• serum prealbumin
• length of stay on ventilator, in ICU, in HOSPITAL
• infectious complications
• outcome (mortality)

Inclusion Criteria:

• 1. anticipated length of stay in ICU >10 days
• 2. moderate to severe malnutrition
• 3. patient tolerating enteral feeds

Exclusion Criteria:

• 1. age < 18 yrs
• 2. known allergy to nandrolone
• 3. women of child bearing age with positive pregancy test
• 4. contraindications to intramuscular injections ie anticoagulation
• 5. renal failure requiring renal replacement therapy
• 6. patients with breast or prostate cancer -

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Lawson Health Research Institute

Overall Clinical Trial Officials and Contacts

Michael D Sharpe, MD FRCPC Principal Investigator London Health Sciences Centre-UC  

Overall Contact: Michael D Sharpe, MD FRCPC 519-663-3030 michael.sharpe@lhsc.on.ca

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00242463

Study ID Number: R-05-390

ClinicalTrials.gov Identifier: NCT00242463

Health Authority: Canada: Health Canada