Acute Kidney InjuryPhase 2PROTEINNCT07880951
Amino Acid Therapy Evaluating the Incidence of New-Onset AKI
A Phase 2 study testing Amino Acid infusion and Lactated Ringer Solution in people with Acute Kidney Injury, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
The goal of this clinical trial is to learn whether giving amino acids through an IV during and after heart surgery can protect the kidneys of children with congenital heart disease. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Amino Acid infusion and Lactated Ringer Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Oct 2027to Oct 2032
- Phase
- Phase 2
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <18 years of age
- a diagnosis of CHD and a planned cardiac surgery requiring CPB that is either a STAT mortality category ≥3 procedure, single-ventricle palliation, or tetralogy of Fallot repair.
Who cannot join
- Known or suspected inborn error of metabolism
- Weight <5 kg
- Known hypersensitivity to amino acids or to Lactated Ringer's
- Neonates <28 days of age receiving concomitant ceftriaxone
- Aspartate aminotransferase or alanine aminotransferase >3× the upper limit of normal for age and sex
- Preterm infants <6 months of age born at <36 weeks gestation
Show all 11Show fewer
- Anuria at the time of randomization
- Preoperative extracorporeal support
- Chronic kidney disease (defined as an estimated GFR <60 mL/min/1.73 m²) -Preoperative AKI by KDIGO criteria
- Receipt of parenteral nutrition at any point during the 7 days before surgery
- Receipt of dialysis of any modality at the time of randomization.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pediatric Randomized Trial Of Amino Acid Therapy Evaluating the Incidence of New Onset AKI
The goal of this clinical trial is to learn whether giving amino acids through an IV during and after heart surgery can protect the kidneys of children with congenital heart disease. Many children who have heart surgery using a heart-lung (bypass) machine develop a sudden decrease in kidney function, called acute kidney injury (AKI). AKI can lead to a longer hospital stay and other complications, and over time it may raise the risk of long-term kidney disease. Children with congenital heart disease often need more than one heart surgery, so their kidneys may face this risk several times. There is currently no treatment proven to prevent AKI in children after heart surgery. Amino acids are the building blocks of protein. Giving amino acids through an IV increases blood flow and oxygen delivery to the kidneys. In adults having heart surgery, this treatment lowered the chance of kidney injury, but it has not been tested in children. The amino acid solution used in this study, TrophAmine, is already used routinely in children's hospitals as part of IV nutrition.
The main questions this study aims to answer are:
Read more
- Does IV amino acid treatment reduce how severe and long-lasting kidney injury is in the first week after heart surgery?
- Does IV amino acid treatment reduce signs of damage to the kidney's cells, measured in urine samples?
- Researchers will compare children who receive the amino acid solution with children who receive a placebo (Lactated Ringer's, a standard IV fluid that does not contain amino acids).
Neither the families nor the medical team will know which solution a child receives. About 270 children younger than 18 years undergoing certain higher-risk heart surgeries will take part at three hospitals: Cincinnati Children's Hospital Medical Center, UPMC Children's Hospital of Pittsburgh, and Nationwide Children's Hospital.
Participants will:
- Be assigned by chance (like flipping a coin) to receive either the amino acid solution or the placebo
- Receive the study solution through an IV for 72 hours, starting in the operating room
- Have routine blood tests during the first week after surgery to check kidney function
- Give urine samples before surgery, 6 to 12 hours after surgery, and on the first and second days after surgery
- Have their health followed for 90 days after surgery, including kidney function, time on a breathing machine, and time in the hospital.
- Conditions
- Acute Kidney Injury
- Being tested
- Amino Acid infusion, Lactated Ringer Solution
- Keywords
- Cardiac bypass, Acute Kidney Injury, Pediatric
- 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 Acid infusionDrug
Also called TrophAmine
Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours.
Lactated Ringer SolutionDrug
Placebo infusion to match the volume of the amino acid infusion in gram/kilogram/day
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid Infusion | Experimental | Amino acid infusion of 2 grams/kg/day; maximum of 100 grams/day Receives: Drug: Amino Acid infusion |
| Lactated Ringer's | Placebo comparator | Volume matched to the Amino Acid Arm Receives: Drug: Lactated Ringer Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Acute Kidney Injury
Acute kidney injury defined by KDIGO serum creatinine criteria lasting greater than 48 hours.
Measured: Acute kidney injury lasting more than 48 hours after cardiopulmonary bypass exposure.
Urine NGAL, KIM-1 and L-FABP levels
Peak postoperative concentration, log-transformed and compared between arms using linear regression.
Measured: preoperatively, 6-12 hours after cardiopulmonary bypass, postoperative days 1-2
Secondary outcomes (4)
Dichotomous AKI
KDIGO ≥1 using serum creatinine or urine output
Measured: During the first 7 postoperative days
MAKE-90
Major Adverse Kidney Events
Measured: 90 days after surgery
Ventilator Free Days
Days off the ventilator after surgery
Measured: 28 days after surgery
Days alive and out of the hospital
Number of days alive and out of the hospital
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2027 (estimated)
- Primary completionOct 2032 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880951
- Sponsor's protocol ID
- 001 - PROTEIN
- Acronym
- PROTEIN
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: With a relatively small data set, participants are at high risk of being re-identified using the data set details.
Publications
Li S, Krawczeski CD, Zappitelli M, Devarajan P, Thiessen-Philbrook H, Coca SG, Kim RW, Parikh CR; TRIBE-AKI Consortium. Incidence, risk factors, and outcomes of acute kidney injury after pediatric cardiac surgery: a prospective multicenter study. Crit Care Med. 2011 Jun;39(6):1493-9. doi: 10.1097/CCM.0b013e31821201d3.
PubMed 21336114Liu Y, Chen S, Zuhlke L, Black GC, Choy MK, Li N, Keavney BD. Global birth prevalence of congenital heart defects 1970-2017: updated systematic review and meta-analysis of 260 studies. Int J Epidemiol. 2019 Apr 1;48(2):455-463. doi: 10.1093/ije/dyz009.
PubMed 30783674Kourelis G, Kanakis M, Samanidis G, Tzannis K, Bobos D, Kousi T, Apostolopoulou S, Kakava F, Kyriakoulis K, Bounta S, Rammos S, Papagiannis J, Giannopoulos N, Orfanos SE, Dimopoulos G. Acute Kidney Injury Predictors and Outcomes after Cardiac Surgery in Children with Congenital Heart Disease: An Observational Cohort Study. Diagnostics (Basel). 2022 Oct 2;12(10):2397. doi: 10.3390/diagnostics12102397.
PubMed 36292086