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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

Sponsored by: 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

MedlinePlus related topics:   Rehabilitation   

ChemIDplus related topics:   Nandrolone    Nandrolone decanoate    Nandrolone phenpropionate   

U.S. FDA Resources

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

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
First Received:   October 19, 2005
Last Updated:   October 25, 2005
ClinicalTrials.gov Identifier:   NCT00242463
Health Authority:   Canada: Health Canada

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

Study placed in the following topic categories:
Nandrolone
Nandrolone phenpropionate
Malnutrition
Critical Illness
Nandrolone decanoate
Nutrition Disorders

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

ClinicalTrials.gov processed this record on September 05, 2008




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