The AminoECMO Pilot Trial

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAustralian and New Zealand Intensive Care Research Centre

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years

Enrolled in the EXCEL Registry

Disqualifiers

Urea level ≥30 mmol/L

Requirement for renal replacement therapy

Chronic hemodialysis or peritoneal dialysis

ECMO for ≥24 hours

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Placebo (Hartmann's balanced crystalloid solution)

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention Arm - Synthamin-17 electrolyte-free solutionActive comparator 1 intervention
Group B: Control Arm - Hartmann's balanced crystalloid solutionPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
24 Hours from randomisation

Secondary outcomes

1

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

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

Other outcomes

1

Number of patients who received AA infusion in the Intervention Group

The total number of participants randomised to the Intervention Group who received AA infusion

Time frame
Up to 48 hours from randomisation
2

Number of patients who received placebo in the control group

The number of participants randomised to the Control Group who received placebo

Time frame
Up to 48 hours post randomisation
3

Mean duration of AA infusion

What was the mean duration of AA infusion in participants who received it?

Time frame
Up to 48 hours post randomisation
4

Enrolment Rate

How many participants were enrolled in the trial from the eligible population?

Time frame
Up to 7 days from commencement of ECMO

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Australian and New Zealand Intensive Care Research Centre

Lead sponsor

Monash University

Collaborator

The Alfred

Collaborator

This trial is not recruiting at the moment. You can still explore other options: