Clinical trial NCT00242463: Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients
Official title: The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malnutrition
Critical Illness
Keywords: malnutrition
anabolic steroids
intensive care unit
rehabilitation
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2005-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: Nitrogen Balance
Secondary outcomes:
measure: Lean body mass
measure: serum prealbumin
measure: length of stay on ventilator, in ICU, in HOSPITAL
measure: infectious complications
measure: outcome (mortality)
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre-UC
state: Ontario
Study officials:
affiliation: London Health Sciences Centre-UC
name: Michael D Sharpe, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1001/jama.281.14.1275.