CompletedPhase 2ACTRN12616000835448

The GAINS trial - Growth and Anabolism in Intensive Care Survivors

The GAINS trial - a randomised controlled double blind pilot study comparing nandrolone and placebo for muscle weakness in Intensive Care Survivors


Sponsor

Sir Charles Gairdner Hospital

Enrollment

20 participants

Start Date

Oct 1, 2017

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 21 YearssMax Age: 85 Yearss

Inclusion Criteria4

  • 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 Criteria10

  • 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

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Interventions

Randomized controlled trial: placebo versus nandrolone administration. Intervention arm: Nandrolone intramuscular injection (IMI) administered weekly for 3 weeks. Dose 100mg females, 200mg males

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.


Locations(2)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

Royal Perth Hospital - Perth

WA, Australia

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