Acute Kidney InjuryPhase 2AminoECMONCT07438262
The AminoECMO Pilot Trial
A Phase 2 study testing Synthamin-17 (10% amino acid solution) in people with Acute Kidney Injury, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Synthamin-17 (10% amino acid solution)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2026to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Enrolled in the EXCEL Registry
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Alfred Hospital
Melbourne, Victoria, 3004
Andrew Udy, BHB, MB ChB, PGCert (AME) PhD, +61 03 9076 8347, A.Udy@alfred.org.au
Emma-Leah Martin, +61 03 9076 8347
About this study
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
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.
Read more
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.
Read the 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 AKI requiring renal replacement therapy (RRT), including 46% in venovenous (V-V) ECMO, and 61% in venoarterial (V-A) ECMO. Severe AKI is associated with significantly worse outcomes and higher mortality, and there is a strong need to identify therapies that can improve renal function in ECMO.
It has already been established that glomerular filtration rate (GFR) increases in response to (IV or enteral) protein administration. The precise mechanism for increased GFR is not completely understood, however recruitment of dormant renal function (called functional renal reserve RFR) has been hypothesised. Amino acid delivery is associated with a renal vasodilation mediated increase renal blood flow by >30%. Different metabolic, endocrine, and paracrine factors have been implicated. It has been suggested that recruitment of RFR could prevent or manage AKI.
Amino Acids Infusions and Preventing AKI The impact of amino acids on renal function has been investigated in clinical trials. This has predominantly occurred in the perioperative setting, in patients with stable renal function undergoing operations associated with a significant risk of developing an AKI. In cardiac surgery, several early-phase studies have demonstrated an improvement in measures of renal function with the perioperative infusion of amino acids. These findings are not isolated to the cardiac surgery population, which may have unique pathological mechanisms for AKI, as a recent pilot RCT in patients undergoing major urology surgery demonstrated a reduction in the incidence of postoperative AKI. Recently a large RCT published in the New England Journal of Medicine showed that the peri-operative administration of amino acids in patients undergoing cardiac surgery significantly decreased the incidence of AKI. Importantly, in a sub group analysis of 232 patients who underwent perioperative mechanical cardiac support, the rate of AKI was lower in the group randomized to amino acids: 44.6 vs 60.8% relative risk 0.73 (0.57-0.94 P=0.01 NNT =6) suggesting a potentially important benefit in this group.
Despite the increasing interest and quantity of research surrounding the association between amino acid infusion and kidney function, several unanswered questions remain. Firstly, although amino acid infusion has been demonstrated to reduce the incidence of AKI when administered before an insult, the impact on renal function in critically ill patients receiving ECMO therapy is unclear, particularly as the insult may have already started to occur prior to ECMO initiation. Secondly, several recent studies of high dose protein have suggested potential harm in patients randomised to a higher dose of protein (2.2g/kg/day vs <1.2g/kg/day) when given over prolonged periods.
The intervention in this pilot differs as it is will commence <24hours post ECMO initiation, and it is given short term only (up to 48 hours). It remains unclear if this will translate to improve renal and patient outcomes.
In summary, ECMO therapy is associated with an increased risk of acute kidney injury. The current management for prevention of AKI is supportive with no current therapies that can decrease the risk of AKI and improve clinical outcomes. Given the physiologically and clinically demonstratable impact of amino acid infusion on renal function, further research is logical and desirable.
- Conditions
- Acute Kidney Injury
- Being tested
- Synthamin-17 (10% amino acid solution), Placebo (Hartmann's balanced crystalloid solution)
- Keywords
- Acute kidney injury, Extracorporeal Membrane Oxygenation, Amino Acids
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo (Hartmann's balanced crystalloid solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 24 hours post randomisation, or will be recorded as a Protocol Deviation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, The Alfred
- Responsible party
- Sponsor
- Investigators
- Carol Hodgson, FAHMS, Study chair, Monash University, School of Public Health and Preventative Medicine, ANZIC-RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438262
- Sponsor's protocol ID
- ANZIC-RC/AB0004
- Acronym
- AminoECMO
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The management committee support the view of the international committee of medical journal editors and the world health organisation (WHO) with reference to the ethical obligation to responsibly share data acquired by interventional clinical trials. At the conclusion of the study, the management committee will consider requests from researchers who provide a methodically sound confidential scientific proposal as per the data sharing policy set out in the ANZIC-RC terms of reference. Only de-identified data will be shared and all requests for data must comply with the ethical, regulatory, and legislative requirements governing their jurisdiction.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07438262
- Acronym / sponsor ID
- AminoECMO / ANZIC-RC/AB0004
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Extracorporeal Membrane Oxygenation, Amino Acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Monash University, The Alfred
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 AKI requiring renal replacement therapy (RRT), including 46% in venovenous (V-V) ECMO, and 61% in venoarterial (V-A) ECMO. Severe AKI is associated with significantly worse outcomes and higher mortality, and there is a strong need to identify therapies that can improve renal function in ECMO.
It has already been established that glomerular filtration rate (GFR) increases in response to (IV or enteral) protein administration. The precise mechanism for increased GFR is not completely understood, however recruitment of dormant renal function (called functional renal reserve RFR) has been hypothesised. Amino acid delivery is associated with a renal vasodilation mediated increase renal blood flow by >30%. Different metabolic, endocrine, and paracrine factors have been implicated. It has been suggested that recruitment of RFR could prevent or manage AKI.
Amino Acids Infusions and Preventing AKI The impact of amino acids on renal function has been investigated in clinical trials. This has predominantly occurred in the perioperative setting, in patients with stable renal function undergoing operations associated with a significant risk of developing an AKI. In cardiac surgery, several early-phase studies have demonstrated an improvement in measures of renal function with the perioperative infusion of amino acids. These findings are not isolated to the cardiac surgery population, which may have unique pathological mechanisms for AKI, as a recent pilot RCT in patients undergoing major urology surgery demonstrated a reduction in the incidence of postoperative AKI. Recently a large RCT published in the New England Journal of Medicine showed that the peri-operative administration of amino acids in patients undergoing cardiac surgery significantly decreased the incidence of AKI. Importantly, in a sub group analysis of 232 patients who underwent perioperative mechanical cardiac support, the rate of AKI was lower in the group randomized to amino acids: 44.6 vs 60.8% relative risk 0.73 (0.57-0.94 P=0.01 NNT =6) suggesting a potentially important benefit in this group.
Despite the increasing interest and quantity of research surrounding the association between amino acid infusion and kidney function, several unanswered questions remain. Firstly, although amino acid infusion has been demonstrated to reduce the incidence of AKI when administered before an insult, the impact on renal function in critically ill patients receiving ECMO therapy is unclear, particularly as the insult may have already started to occur prior to ECMO initiation. Secondly, several recent studies of high dose protein have suggested potential harm in patients randomised to a higher dose of protein (2.2g/kg/day vs <1.2g/kg/day) when given over prolonged periods.
The intervention in this pilot differs as it is will commence <24hours post ECMO initiation, and it is given short term only (up to 48 hours). It remains unclear if this will translate to improve renal and patient outcomes.
In summary, ECMO therapy is associated with an increased risk of acute kidney injury. The current management for prevention of AKI is supportive with no current therapies that can decrease the risk of AKI and improve clinical outcomes. Given the physiologically and clinically demonstratable impact of amino acid infusion on renal function, further research is logical and desirable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Synthamin-17 electrolyte-free solution | Active comparator | Dietary Supplement: Synthamin-17 (10% amino acid 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. |
| Control Arm - Hartmann's balanced crystalloid solution | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥18 years
- Enrolled in the EXCEL Registry
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Intervention Arm - Synthamin-17 electrolyte-free solution |
| 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. | Other | Control Arm - Hartmann's balanced crystalloid solution |
Primary outcome
The number of patients who received AA infusion within 24 hours of being randomised in the trial after ECMO initiation.
Time frame: 24 Hours from randomisation
Participants randomised to the Intervention Group who received AA infusion within the 24 hour study time frame.
1 secondary outcome
Number of hours post randomisation that AA infusion was commenced in the intervention group
Time frame: Up to 24 hours post randomisation, or will be recorded as a Protocol Deviation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. The management committee support the view of the international committee of medical journal editors and the world health organisation (WHO) with reference to the ethical obligation to responsibly share data acquired by interventional clinical trials. At the conclusion of the study, the management committee will consider requests from researchers who provide a methodically sound confidential scientific proposal as per the data sharing policy set out in the ANZIC-RC terms of reference. Only de-identified data will be shared and all requests for data must comply with the ethical, regulatory, and legislative requirements governing their jurisdiction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carol Hodgson, FAHMS study chair
Monash University, School of Public Health and Preventative Medicine, ANZIC-RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synthamin-17 (10% amino acid solution) in people with Acute Kidney Injury, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aidan Burrell, MBBS, FCICM, DDU, PhD (+61 422 848 716, aidanburrell@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who received AA infusion within 24 hours of being randomised in the trial after ECMO initiation. (time frame: 24 Hours from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.