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Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
Sponsor: Stuart Goldstein, MD
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.
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-04-01
Completion Date
2027-12-31
Last Updated
2026-03-23
Healthy Volunteers
No
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
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States