RecruitingPhase 2Phase 3ACTRN12623000729628

Muscle growth and anabolism in intensive care survivors

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

Sponsor

Sir Charles Gairdner Hospital

Enrollment

60 participants

Start Date

Jul 5, 2023

Study Type

Interventional

Conditions

Intensive Care Critical illness nutrition

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Spending a long time in the intensive care unit (ICU) can leave lasting effects on the body, including significant muscle weakness that can affect mobility and quality of life for months or years afterwards. One factor contributing to this weakness is very low levels of testosterone — even in people who would normally have healthy levels — which disrupts the body's ability to build and maintain muscle. This trial is testing whether giving survivors of prolonged critical illness a synthetic form of testosterone called nandrolone — by injection once a week for up to three weeks — can help rebuild muscle strength and speed up recovery. Both groups will continue to receive standard ICU care, including physiotherapy. Researchers will track muscle strength, the time it takes until a patient can walk with assistance, length of hospital stay, and physical function at three months. You may be eligible if you are 21 years or older, are in an ICU or high dependency unit, have been there for at least five days (or have significant weakness from your ICU stay), and are receiving adequate nutrition. People with active cardiac events, prostate or breast cancer, active septic shock, or pregnancy are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Randomised controlled trial placebo versus nandrolone administration. Intervention arm: Nandrolone intramuscular injection (IMI) administered weekly for 3 weeks. Dose 50mg females, 100mg males

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.