Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

NCT ID: NCT00242463

Last Updated: 2011-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-10-31

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.

Conditions

Malnutrition; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

nandrolone

Patients receive weekly injections of nandrolone

Group Type: EXPERIMENTAL

Nandrolone (anabolic steroid)

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Nandrolone (anabolic steroid)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Lawson Health Research Institute

Principal Investigators

Michael D Sharpe, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre-UC

Locations

London Health Sciences Centre-UC

London, Ontario, Canada

Countries

Canada

References

Chang DW, DeSanti L, Demling RH. Anticatabolic and anabolic strategies in critical illness: a review of current treatment modalities. Shock. 1998 Sep;10(3):155-60. doi: 10.1097/00024382-199809000-00001.

Reference Type: BACKGROUND

PMID: 9744642 (View on PubMed)

Johansen KL, Mulligan K, Schambelan M. Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial. JAMA. 1999 Apr 14;281(14):1275-81. doi: 10.1001/jama.281.14.1275.

Reference Type: BACKGROUND

PMID: 10208142 (View on PubMed)

Other Identifiers

11582

Identifier Type: OTHER

Identifier Source: secondary_id

R-05-390

Identifier Type: -

Identifier Source: org_study_id