The AminoECMO Pilot Trial

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAustralian and New Zealand Intensive Care Research Centre

About this trial

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.

Eligibility criteria

Qualifiers

Aged ≥18 years

Enrolled in the EXCEL Registry

Disqualifiers

Urea level ≥30 mmol/L

Requirement for renal replacement therapy

Chronic hemodialysis or peritoneal dialysis

ECMO for ≥24 hours

Trial design

Treatments tested in this trial

  • Synthamin-17 (10% amino acid solution)
  • Placebo (Hartmann's balanced crystalloid solution)

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Australian and New Zealand Intensive Care Research Centre

Lead sponsor

Monash University

Collaborator

The Alfred

Collaborator