Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

Condition(s) targeted: Malnutrition; Critical Illness

Intervention: Nandrolone (anabolic steroid) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
Michael D Sharpe, MD FRCPC, Principal Investigator, Affiliation: London Health Sciences Centre-UC

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

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.

Official title: The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Nitrogen Balance

Secondary outcome:

Lean body mass

serum prealbumin

length of stay on ventilator, in ICU, in HOSPITAL

infectious complications

outcome (mortality)

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 -

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

London Health Sciences Centre-UC, London, Ontario N6A5A5, Canada; Recruiting
Michael D Sharpe, MD FRCPC, Phone: 519-663-3030, Email: michael.sharpe@lhsc.on.ca
Michael D Sharpe, MD FRCPC, Principal Investigator

Related publications:

Chang DW, DeSanti L, Demling RH. Anticatabolic and anabolic strategies in critical illness: a review of current treatment modalities. Shock. 1998 Sep;10(3):155-60. Review.

Johansen KL, Mulligan K, Schambelan M. Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial. JAMA. 1999 Apr 14;281(14):1275-81.

Starting date: October 2005
Last updated: October 25, 2005