Recruiting
Phase 2

Amino Acids

Sponsor:

Dana Fuhrman

Code:

NCT07212595

Conditions

Acute Kidney Injury

Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Amino Acid infusion

Lactated ringers solution

Study Details

Brief summary:

The goal of the BRAVE-HEART study is to learn if an amino acid infusion can reduce the risk of developing acute kidney injury after cardiac surgery in children. The main questions it aims to answer are:

1. Does an amino acid infusion decrease the number of participants with acute kidney injury?
2. Does an amino acid infusion decrease the number of days that participants are on a ventilator after cardiac surgery?

Researchers will compare amino acids to a placebo (a look-alike substance that contains no drug) to see if amino acids decrease the number of participants with acute kidney injury.

Participants will receive an amino acid or placebo infusion for up to 72 hours starting during cardiac surgery and only while in the operating room or the intensive care unit.

Conditions

Acute Kidney Injury

Mechanical Ventilation

Study ID

NCT07212595

Start date

Jul 8, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Expected to be at high risk of developing acute kidney injury after cardiac surgery based on Age, The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score, and anticipated cardiopulmonary bypass time
  • Age less than or equal to 18 years
  • Weight greater than or equal to 5 kilograms

Exclusion Criteria:

  • Preoperative extracorporeal organ support
  • History of chronic kidney disease
  • Known or suspected inborn errors of amino acid metabolism
  • Known hypersensitivity to amino acids
  • Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3 times the upper limit of normal for age/gender
  • Preterm infants less than 6 months of age who were born at less than 36 weeks gestational age
  • Anuria at the time of randomization
  • Expected use of total parental nutrition (TPN) within the first 72 hours post-operatively

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Acid Acid Infusion

Amino Acid Infusion for up to 72 hours

placebo comparator: Placebo Infusion

Placebo Infusion for up to 72 hours

Interventions

Amino Acid infusion

Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours

Lactated ringers solution

Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day

Primary outcome measure

  • Rate of acute kidney injury on post-operative days 2, 3, or 4 [ Time Frame: From enrollment to post-operative day 4 ]
  • Rate of mechanical ventilation at 96 hours post-operatively [ Time Frame: From enrollment to 96 hours post-operatively ]

Central Contacts and Locations

Central contacts

Kelli Krallman, RN, BSN, MS

513-636-4837kelli.krallman@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Clinical Research Manager

513-636-4837kelli.krallman@cchmc.org

Principal Investigator:

Stuart Goldstein, MD

More Information

Sponsor

Dana Fuhrman

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Cardiac Bypass
  • Pediatric
  • Acute Kidney Injury
  • Amino Acids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dana Fuhrman on 2026-07-24.