Muscle growth and anabolism in intensive care survivors
Nandrolone versus placebo for muscle weakness in Intensive Care Survivors: a randomised controlled trial
Sir Charles Gairdner Hospital
60 participants
Jul 5, 2023
Interventional
Conditions
Summary
Intensive care patients can face significant health issues that extend beyond their Intensive Care Unit (ICU) stay. Despite recent advances it is estimated that one-quarter to one-half of long-stay intensive care survivors live with significant weakness as a consequence of their illness, resulting in impaired mobility and function. The loss of muscle mass in critical illness is related to immobility and a complicated process that causes muscle and nerve dysfunction called critical illness polymyoneuropathy. Another contributory factor is low levels of anabolic (muscle building) hormones such as testosterone – with testosterone levels in critically ill patients are extremely low, even in the recovery phase from acute illness. One potential treatment may be to provide anabolic support in the recovery phase from prolonged critical illness. This project aims to test whether giving a synthetic testosterone (nandrolone), will improve muscle strength in ICU survivors, when compared to placebo. Previous research has already established that early physiotherapy in the ICU can reduce length of stay and improve patients outcomes. In this study, both groups will receive standard care, which includes early physiotherapy. Nandrolone or placebo will be administered intramuscularly weekly for up to 3 weeks. Outcome measures will include hospital length of stay, time until the patient walks with assistance, muscle strength (globally and grip strength) as well as the patient’s physical functioning at 3 months following enrolment. The study design will be a double blinded randomised controlled trial. The teams involved are multi-disciplinary, involving physiotherapy, dietitians, pharmacy as well as medical specialists. The investigators have already successfully conducted a pilot feasibility trial of a nandrolone versus placebo, showing that the intervention is safe and feasible
Eligibility
Inclusion Criteria6
- At least 21 years of age
- Admitted to participating ICU/HDU
- Receiving nutrition at estimated goals for at least 24 hours
- ICU/HDU length of stay => 5 days
- OR
- Significant weakness as deemed by treating clinician below patient’s baseline as a result of the ICU stay
Exclusion Criteria13
- Intercurrent septic shock (fevers, broad spectrum anti-microbials, and needing vasopressors)
- Active cardiac disease (such as STEMI/NSTEMI in last 2 weeks) or EF <35%
- Prostate or breast cancer
- Ongoing reason for catabolic state (active malignancy, HIV & opportunistic infection last 2 months)
- Unable to engage in rehabilitation (due to significant neurological or orthopaedic issues)
- Normal age-related level of serum testosterone in males (measured in early morning 6-9am)
- Pregnancy or breast-feeding
- Any known allergies to nandrolone components – including peanuts and soya and latex.
- Elevated LFTs (ALT > 5x normal) and impaired bilirubin excretion
- Polycythaemia (Hb > 165 males, > 150 females)
- Nephrotic syndrome.
- Athletes competing in international/national events.
- Expected death within the next week
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Randomised controlled trial placebo versus nandrolone administration. Intervention arm: Nandrolone intramuscular injection (IMI) administered weekly for 3 weeks. Dose 50mg females, 100mg males Intervention will be administered by blinded investigators to inpatients so adherence will not be a problem.
Locations(3)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12623000729628