Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

Phase 2

Terminated

• Conditions: Malnutrition; Critical Illness
• Interventions: Drug: Nandrolone (anabolic steroid); Drug: Placebo

• Registration Number: NCT00242463
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-20
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-04
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. anticipated length of stay in ICU >10 days
2. moderate to severe malnutrition
3. patient tolerating enteral feeds

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nandrolone	Nandrolone (anabolic steroid)	Patients receive weekly injections of nandrolone
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Nitrogen Balance

Secondary Outcome Measures

Name	Time	Method
Lean body mass
serum prealbumin
length of stay on ventilator, in ICU, in HOSPITAL
infectious complications
outcome (mortality)

Trial Locations

Locations (1)

London Health Sciences Centre-UC; 🇨🇦 London, Ontario, Canada