Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients
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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 |
- Nitrogen Balance
- 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 |
Inclusion Criteria:
- anticipated length of stay in ICU >10 days
- moderate to severe malnutrition
- patient tolerating enteral feeds
Exclusion Criteria:
- age < 18 yrs
- known allergy to nandrolone
- women of child bearing age with positive pregnancy test
- contraindications to intramuscular injections ie anticoagulation
- renal failure requiring renal replacement therapy
- patients with breast or prostate cancer -
Contacts and Locations| Canada, Ontario | |
| London Health Sciences Centre-UC | |
| London, Ontario, Canada, N6A5A5 | |
| 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 Disease Attributes Pathologic Processes Nutrition Disorders Nandrolone Nandrolone decanoate |
Nandrolone phenpropionate Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anabolic Agents |
ClinicalTrials.gov processed this record on May 22, 2013