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NOT YET RECRUITING
NCT07438262
PHASE2

The AminoECMO Pilot Trial

Sponsor: Australian and New Zealand Intensive Care Research Centre

View on ClinicalTrials.gov

Summary

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.

Official title: A Pilot, Three-centre, Placebo Controlled, Physiology and Feasibility Randomised Controlled Trial of Intravenous Amino Acid Therapy in ECMO Dependent Adults Admitted to the Intensive Care Unit

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-01

Completion Date

2027-11-30

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Synthamin-17 (10% amino acid solution)

First time comparing amino acid to placebo for prevention of acute kidney injury in patients receiving extracorporeal membrane oxygenation

OTHER

Placebo (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.

Locations (1)

Alfred Hospital

Melbourne, Victoria, Australia