Status:
NOT_YET_RECRUITING
Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
Lead Sponsor:
Stuart Goldstein, MD
Collaborating Sponsors:
Congenital Heart Alliance of Cincinnati
Conditions:
Acute Kidney Injury
Mechanical Ventilation
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07212595
Start Date
November 1 2025
End Date
December 1 2026
Last Update
October 8 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229