The AminoECMO Pilot Trial

NCT07438262 | Not Yet Recruiting Phase 2

• 1 other identifier: ANZIC-RC/AB0004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Acute Kidney Injury

Keywords

Acute kidney injury; Extracorporeal Membrane Oxygenation; Amino Acids

Outcome Measures

Primary Outcomes (1)

• The number of patients who received AA infusion within 24 hours of being randomised in the trial after ECMO initiation.

  Participants randomised to the Intervention Group who received AA infusion within the 24 hour study time frame.

  24 Hours from randomisation

Secondary Outcomes (1)

• Number of hours post randomisation that AA infusion was commenced in the intervention group

  Up to 24 hours post randomisation, or will be recorded as a Protocol Deviation

Other Outcomes (15)

• Number of patients who received AA infusion in the Intervention Group

  Up to 48 hours from randomisation

• Number of patients who received placebo in the control group

  Up to 48 hours post randomisation

• Mean duration of AA infusion

  Up to 48 hours post randomisation

Study Arms (2)

Intervention Arm - Synthamin-17 electrolyte-free solution

ACTIVE COMPARATOR

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.

Dietary Supplement: Synthamin-17 (10% amino acid solution)

Control Arm - Hartmann's balanced crystalloid solution

PLACEBO COMPARATOR

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.

Other: Placebo (Hartmann's balanced crystalloid solution)

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

Intervention Arm - Synthamin-17 electrolyte-free solution

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.

Control Arm - Hartmann's balanced crystalloid solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years
• Enrolled in the EXCEL Registry

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Monash University: collaborator
• The Alfred: collaborator

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Carol Hodgson, FAHMS

  Monash University, School of Public Health and Preventative Medicine, ANZIC-RC

  STUDY CHAIR

Central Study Contacts

Aidan Burrell, MBBS, FCICM, DDU, PhD

CONTACT

+61 422 848 716; aidanburrell@gmail.com

Stephanie M Hunter, BN, PhD

CONTACT

+61 422 033 612; Stephanie.Hunter@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot, multi-centre, registry embedded, randomised controlled trial testing the feasibility of administering an interventional product (amino acid) compared to administering a placebo within 24 hours of randomisation, after commencing ECMO.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Supporting information will be available from October 2026, and there will be no specified end date that this information can be accessed.
• Access Criteria: The Study Protocol and Statistical Analysis Plan will both be available on the Monash ANZIC-RC site from October 2026 onward.

Locations

AU (1)