The AminoECMO Pilot Trial

Sponsor
Australian and New Zealand Intensive Care Research Centre
Study ID
NCT07438262
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Synthamin-17 (10% amino acid solution) — DIETARY_SUPPLEMENT
    First time comparing amino acid to placebo for prevention of acute kidney injury in patients receiving extracorporeal membrane oxygenation
  • Placebo (Hartmann's balanced crystalloid solution) — OTHER
    Participants allocated to the control group will receive placebo comprised of Hartmann's balanced crystalloid solution (compound sodium lactate) to a maximum of 500mls and 48-hours.

Study Details

Acute kidney injury (AKI) is a serious problem for patients in intensive care, especially those on life-support machines like ECMO (which helps the heart and lungs). More than half of these patients develop severe kidney problems that often require dialysis, and this greatly increases the risk of poor outcomes. Doctors try to prevent AKI by treating the underlying illness, avoiding kidney-harming drugs, and carefully managing fluids. But these methods are mostly supportive - they don't actively improve kidney function. Studies in surgical patients (especially heart and urology operations) show that giving amino acids before surgery can reduce the chance of developing AKI. A major clinical trial even found that this approach significantly lowered AKI rates in heart surgery patients. Amino acids (the building blocks of protein) seem to boost kidney performance. When given through a drip or feeding tube, they increase blood flow to the kidneys and may "wake up" unused kidney capacity - a concept called "functional renal reserve." It's not yet clear whether amino acids help critically ill patients on ECMO. More research is needed to see if this promising strategy can improve kidney function and outcomes in the sickest patients.

Key Dates

First listed
Feb 27, 2026
Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Aug 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intervention Arm - Synthamin-17 electrolyte-free solution
    The study drug within the intervention arm will be continually infused for up to 48 hours whilst the patient is on ECMO. The infusion rate will be set to 2g/kg/ideal body weight/day (to a maximum of 100g). Patients enrolled into the control arm will be continually infused with a placebo for up to 48 hours whilst on ECMO.
  • Placebo Comparator: Control Arm - Hartmann's balanced crystalloid solution
    Participants allocated to the control group will receive placebo comprised of Hartmann's balanced crystalloid solution (compound sodium lactate) to a maximum of 500mls and 48-hours.

Primary Outcome Measure

The number of patients who received AA infusion within 24 hours of being randomised in the trial after ECMO initiation. [ Time Frame: 24 Hours from randomisation ]

Central Contacts

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