Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00242463
• Other study ID #: R-05-390
• Secondary ID: 11582
• Status: Terminated
• Phase: Phase 2
• First received: October 19, 2005
• Last updated: January 4, 2011
• Start date: October 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2011
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Malnutrition

Intervention

Drug:
• Nandrolone (anabolic steroid)

• Placebo

Locations

Country	Name	City	State
Canada	London Health Sciences Centre-UC	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nitrogen Balance
Secondary	Lean body mass
Secondary	serum prealbumin
Secondary	length of stay on ventilator, in ICU, in HOSPITAL
Secondary	infectious complications
Secondary	outcome (mortality)