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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Synthamin-17 (10% amino acid solution)
Dietary supplementFirst 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 interventionParticipants 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Other outcomes
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
Number of patients who received placebo in the control group
The number of participants randomised to the Control Group who received placebo
Mean duration of AA infusion
What was the mean duration of AA infusion in participants who received it?
Enrolment Rate
How many participants were enrolled in the trial from the eligible population?
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: