None listed
Conditions
Brief summary
ICU acquired weakness, the result of catabolism, immobility and critical illness polymyoneuropathy is of significant consequence to long-stay ICU patients. Recent advances have tried to prevent ICU acquired weakness by early mobilisation of patients and optimising nutrition. The loss of lean body mass in critical illness is also associated with misalignment between catabolic and anabolic hormones. One potential treatment may be to provide anabolic support in the recovery phase from prolonged critical illness. Nandrolone is a synthetic anabolic steroid that has greater anabolic (growth) and less androgenic (masculinizing) properties than testosterone. It has previously been used successfully in patients with weight loss in HIV/AIDS, and muscle wasting in patients with chronic obstructive pulmonary disease and end stage renal failure. This is a pilot multicentre randomized placebo controlled trial that will look at the effects of nandrolone given weekly for three weeks, versus placebo, in patients who have lost significant amounts of weight or strength while in the ICU. Our primary outcome will be changes in muscle strength, but we will also be looking for changes in weight and length of stay.
Interventions
Randomized controlled trial: placebo versus nandrolone administration.
Intervention arm: Nandrolone intramuscular injection (IMI) administered weekly for 3 weeks.
Dose 100mg females, 200mg males
Intervention will be administered by blinded investigators to inpatients so adherence will not be a problem.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Admitted To Intensive Care Unit or High Dependency Unit Significant weakness as result of ICU stay or pre-ICU condition as deemed by the treating clinician Weight loss (BMI < 20 or >10% weight loss in last 6 months) Receiving nutritional inputs at estimated goals for at least 3 days
Exclusion criteria
Intercurrent septic shock (infection + vasopressors) Prostate or breast cancer Active cardiac disease (STEMI/NSTEMI last 2 weeks) or EF < 35% Ongoing non-curable reason for catabolic state (such as active malignancy, HIV with opportunistic infection in last 2 months, inadequate nutritional intake) Unable to engage in rehabilitation (due to significant neurological or orthopaedic issues) Normal age related level of serum testosterone Pregnancy or breast feeding Any known allergies to nandrolone components (peanuts, soya, latex) Elevated LFTS (ALT > 5 x normal) and impaired bilirubin excretion Nephrotic syndrome (>3 g proteinuria/day
Outcome results
None listed