NCT07212595PHASE2Recruiting

Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy

Dana Fuhrman

Start Date

7/8/2026

Completion Date

12/31/2027

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.

Eligibility Criteria

Age Range: No minimum to 18 years

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

Interventions

DRUG

Amino Acid infusion

DRUG

Lactated ringers solution

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Conditions

Acute Kidney InjuryMechanical Ventilation

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States