Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT00242463
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nandrolone (anabolic steroid)
  • Drug: Placebo
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients
Study Start Date :
Oct 1, 2005
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: nandrolone

Patients receive weekly injections of nandrolone

Drug: Nandrolone (anabolic steroid)

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Nitrogen Balance []

Secondary Outcome Measures

  1. Lean body mass []

  2. serum prealbumin []

  3. length of stay on ventilator, in ICU, in HOSPITAL []

  4. infectious complications []

  5. outcome (mortality) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 pregnancy test

  4. contraindications to intramuscular injections ie anticoagulation

  5. renal failure requiring renal replacement therapy

  6. patients with breast or prostate cancer -

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Sciences Centre-UC London Ontario Canada N6A5A5

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00242463
Other Study ID Numbers:
  • R-05-390
  • 11582
First Posted:
Oct 20, 2005
Last Update Posted:
Jan 5, 2011
Last Verified:
Jan 1, 2011

Study Results

No Results Posted as of Jan 5, 2011