Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

This study has been terminated.
(drug no longer available in canada)
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00242463
First received: October 19, 2005
Last updated: January 4, 2011
Last verified: January 2011
  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 demonstrate an improvement in clinical outcome.


Condition Intervention Phase
Malnutrition
Critical Illness
Drug: Nandrolone (anabolic steroid)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nandrolone
Patients receive weekly injections of nandrolone
Drug: Nandrolone (anabolic steroid)
Placebo Comparator: Placebo Drug: Placebo

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242463

Locations
Canada, Ontario
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
  More Information

Publications:
Responsible Party: Dr. M. Sharpe, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00242463     History of Changes
Other Study ID Numbers: R-05-390, 11582
Study First Received: October 19, 2005
Last Updated: January 4, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 22, 2014