Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients

Conditions
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Malnutrition, Critical Illness

Intervention / Treatment
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* Drug: Nandrolone (anabolic steroid)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nandrolone<br>Patients receive weekly injections of nandrolone | Drug: Nandrolone (anabolic steroid)<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitrogen Balance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass |  |  | 
| serum prealbumin |  |  | 
| length of stay on ventilator, in ICU, in HOSPITAL |  |  | 
| infectious complications |  |  | 
| outcome (mortality) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, anabolic steroids, intensive care unit, rehabilitation