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Muscle growth and anabolism in intensive care survivors

Nandrolone versus placebo for muscle weakness in Intensive Care Survivors: a randomised controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000729628
Acronym
GAINS 2.0
Enrollment
25
Registered
2023-07-05
Start date
2023-07-05
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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.

Sponsors

Sir Charles Gairdner Hospital
Lead SponsorHospital

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
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1.) At least 21 years of age 2.) Admitted to participating ICU/HDU 3.) Receiving nutrition at estimated goals for at least 24 hours 4.) 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 criteria

1.) Intercurrent septic shock (fevers, broad spectrum anti-microbials, and needing vasopressors) 2. Active cardiac disease (such as STEMI/NSTEMI in last 2 weeks) or EF <35% 3. Prostate or breast cancer 4. Ongoing reason for catabolic state (active malignancy, HIV & opportunistic infection last 2 months) 5. Unable to engage in rehabilitation (due to significant neurological or orthopaedic issues) 6. Normal age-related level of serum testosterone in males (measured in early morning 6-9am) 7. Pregnancy or breast-feeding 8. Any known allergies to nandrolone components – including peanuts and soya and latex. 9. Elevated LFTs (ALT > 5x normal) and impaired bilirubin excretion 10. Polycythaemia (Hb > 165 males, > 150 females) 11. Nephrotic syndrome. 12. Athletes competing in international/national events. 13. Expected death within the next week

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026