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NOT YET RECRUITING
NCT07212595
PHASE2

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

Sponsor: Stuart Goldstein, MD

View on ClinicalTrials.gov

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

DRUG

Amino Acid infusion

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

DRUG

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