MedTrace Logo

The AminoECMO Pilot Trial

NCT07438262 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Monash University

    collaborator OTHER

  • The Alfred

    collaborator OTHER

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Carol Hodgson, FAHMS · Monash University, School of Public Health and Preventative Medicine, ANZIC-RC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-08-30
Completion
2027-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07438262 on ClinicalTrials.gov