Acute Kidney InjuryPhase 2AKINCT07001098
Amino Acids for Cardiac Surgery Associated AKI
A Phase 2 study testing Amino Acids in people with Acute Kidney Injury, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Amino Acids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Nov 2026
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Undergoing cardiac surgery and expected to be high risk
Who cannot join
- preoperative extracorporeal organ support
- CKD history (GFR<60ml/min/1.73m2 [≤1year] and GFR<90ml/min/1.73m2 [>1 year])
- serum creatinine defined preoperative AKI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94305
About this study
Official title: Amino Acids for the Infant at Risk for Acute Kidney Injury After Cardiac Surgery: A Pilot Study
The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.
- Conditions
- Acute Kidney Injury
- Being tested
- Amino Acids, Placebo
- Keywords
- cardiac surgery
- 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.
Amino AcidsDrug
Also called AA, Trophamine
The participants receive a continuous infusion of a balanced mixture of amino acids (Trophamine) in a dose of 2g/kg/day (max 100g/day) starting at the time of cardiac surgery up to 3 days
PlaceboDrug
Also called Lactated Ringer
The participants receive a continuous infusion of a lactated ringers (placebo), equivalent volume to amino acids, starting at the time of cardiac surgery up to 3 days
| Study group | Role | What they receive |
|---|---|---|
| Amino acid | Experimental | Participants receive amino acids for up to 3 days starting at the time of their cardiac surgery Receives: Drug: Amino Acids |
| Placebo | Placebo comparator | Participants receive equivalent volume of placebo for up to 3 days starting at the time of their cardiac surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Amino acids Related Adverse Events
Measured: Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shina Menon, Stanford University
- Investigators
- Shina Menon, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001098
- Sponsor's protocol ID
- 80133
- Acronym
- AKI
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acids for the Infant at Risk for Acute Kidney Injury After Cardiac Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT07001098
- Acronym / sponsor ID
- AKI / 80133
- Conditions
- Acute Kidney Injury
- Keywords
- cardiac surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 Jun 2025 (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.
The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino acid | Experimental | Drug: Amino AcidsParticipants receive amino acids for up to 3 days starting at the time of their cardiac surgery |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive equivalent volume of placebo for up to 3 days starting at the time of their cardiac surgery |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Undergoing cardiac surgery and expected to be high risk
Key exclusion criteria (3 listed)
- preoperative extracorporeal organ support
- CKD history (GFR<60ml/min/1.73m2 [≤1year] and GFR<90ml/min/1.73m2 [>1 year])
- serum creatinine defined preoperative AKI.
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 |
|---|---|---|
| Amino AcidsAlso: AA, TrophamineThe participants receive a continuous infusion of a balanced mixture of amino acids (Trophamine) in a dose of 2g/kg/day (max 100g/day) starting at the time of cardiac surgery up to 3 days | Drug | Amino acid |
| PlaceboAlso: Lactated RingerThe participants receive a continuous infusion of a lactated ringers (placebo), equivalent volume to amino acids, starting at the time of cardiac surgery up to 3 days | Drug | Placebo |
Primary outcome
Number of Participants with Amino acids Related Adverse Events
Time frame: Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days)
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 3 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Shina Menon, MD principal investigator
Stanford University
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 Amino Acids in people with Acute Kidney Injury, run by Stanford University at 1 site in United States.
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 1 inclusion and 3 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 3 Jun 2025. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Amino acids Related Adverse Events (time frame: Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days)). 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 3 Jun 2025.