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Clinical Trials in Australia / NCT07438262
Starting soon Phase 2

The AminoECMO Pilot Trial

NCT07438262 · tracked via the Priya Life Science Australia tracker
Sponsor
Australian and New Zealand Intensive Care Research Centre
Phase
Phase 2
Started
2026-02-01
Last updated
2026-02-27

Condition(s) studied

Acute Kidney Injury

Investigational drug(s) / intervention(s)

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

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

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Aged ≥18 years * Enrolled in the EXCEL Registry Exclusion Criteria: * Urea level ≥30 mmol/L * Requirement for renal replacement therapy * Chronic hemodialysis or peritoneal dialysis * ECMO for ≥24 hours * Pre-admission CKD with an eGFR \<30 ml/min * Previous enrolment in this study * Pregnant or Lactating * Known contraindication to AA infusion * ECMO expected to cease ≤24 hours * Expected to be transferred to another hospital ≤24 hours * Treating clinical team deems study is not in the patient's best interest

Primary outcome measure(s)

  • The number of patients who received AA infusion within 24 hours of being randomised in the trial after ECMO initiation. — 24 Hours from randomisation
    Participants randomised to the Intervention Group who received AA infusion within the 24 hour study time frame.

Trial sites (1)

FacilityCityRegionStatus
Alfred Hospital Melbourne Victoria

More Australian and New Zealand Intensive Care Research Centre trials in Australia

The CPR, Pre-hospital ECPR and Early Reperfusion Study: A Target Trial Emulation Active, not recruiting
Red Blood Cell Transfusion in ECMO - A Feasibility Trial Recruiting
Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults Recruiting
The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III)) Enrolling by invitation
Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure Recruiting

Other trials for the same condition

Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery Recruiting
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07438262 on ClinicalTrials.gov ↗ ← All trials in Australia