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| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2005 |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Michael D Sharpe, MD FRCPC | 519-663-3030 | michael.sharpe@lhsc.on.ca |
| 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 | |
| Principal Investigator: | Michael D Sharpe, MD FRCPC | London Health Sciences Centre-UC |
More Information
| 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 |
|
malnutrition anabolic steroids intensive care unit rehabilitation |
|
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 |