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Clinical Trial NCT07438262 (AminoECMO) for Acute Kidney Injury is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The AminoECMO Pilot Trial Phase 2 40

Not yet recruiting
Clinical Trial NCT07438262 (AminoECMO) is designed to study Prevention for Acute Kidney Injury. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 February 2026 until the study accrues 40 participants. Led by Australian and New Zealand Intensive Care Research Centre, this study is expected to complete by 30 November 2027. The latest data from ClinicalTrials.gov was last updated on 27 February 2026.
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 carefull...

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Detailed Description
Acute kidney injury (AKI) is common in critically ill patients, especially in those requiring extracorporeal membrane oxygenation (ECMO). AKI is associated with significant morbidity and mortality. The current management for the prevention of AKI is supportive, such as treating underlying causes, avoiding nephrotoxins, and optimising fluid status. Despite optimal care, more than half of ECMO patients develop severe A...Show More
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

Conditions
Acute Kidney Injury
Other Study IDs
  • AminoECMO
  • ANZIC-RC/AB0004
NCT ID Number
NCT07438262
Start Date (Actual)
2026-02-01
Last Update Posted
2026-02-27
Completion Date (Estimated)
2027-11-30
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Acute kidney injury
Extracorporeal Membrane Oxygenation
Amino Acids
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorIntervention Arm - Synthamin-17 electrolyte-free solution
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.
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 ComparatorControl Arm - 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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of hours post randomisation that AA infusion was commenced in the intervention group
Date and time of randomisation and date and time that AA infusion was commenced
Up to 24 hours post randomisation, or will be recorded as a Protocol Deviation
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Aged ≥18 years
  • Enrolled in the EXCEL Registry

  • 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
Australian and New Zealand Intensive Care Research Centre logoAustralian and New Zealand Intensive Care Research Centre
  • Monash University logoMonash University
  • The Alfred logoThe Alfred
Study Central Contact
Contact: Aidan Burrell, MBBS, FCICM, DDU, PhD, +61 422 848 716, [email protected]
Contact: Stephanie M Hunter, BN, PhD, +61 422 033 612, [email protected]
1 Study Locations in 1 Countries

Victoria

Alfred Hospital, Melbourne, Victoria, 3004, Australia
Andrew Udy, BHB, MB ChB, PGCert (AME) PhD, Contact, +61 03 9076 8347, [email protected]
Emma-Leah Martin, Contact, +61 03 9076 8347