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Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients
This study is currently recruiting participants.
Verified by Lawson Health Research Institute, October 2005
First Received: October 19, 2005   Last Updated: October 25, 2005   History of Changes
Sponsor: Lawson Health Research Institute
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00242463
  Purpose

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.


Condition Intervention Phase
Malnutrition
Critical Illness
Drug: Nandrolone (anabolic steroid)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Nitrogen Balance

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

Estimated Enrollment: 20
Study Start Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242463

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

Locations
Canada, Ontario
London Health Sciences Centre-UC Recruiting
London, Ontario, Canada, N6A5A5
Contact: Michael D Sharpe, MD FRCPC     519-663-3030     michael.sharpe@lhsc.on.ca    
Principal Investigator: Michael D Sharpe, MD FRCPC            
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre-UC
  More Information

Publications:
Study ID Numbers: R-05-390
Study First Received: October 19, 2005
Last Updated: October 25, 2005
ClinicalTrials.gov Identifier: NCT00242463     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
malnutrition
anabolic steroids
intensive care unit
rehabilitation

Additional relevant MeSH terms:
Nandrolone
Anabolic Agents
Disease Attributes
Pathologic Processes
Malnutrition
Critical Illness
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Nutrition Disorders
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on February 08, 2010