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

Not Applicable

Not yet recruiting

• Conditions: Acute Kidney Injury; Mechanical Ventilation
• Interventions: Drug: Amino Acid infusion; Drug: Lactated ringers solution

• Registration Number: NCT07212595
• Lead Sponsor: Stuart Goldstein, MD

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-28
• Study First Submitted QC: 2025-10-06
• Last Update Submitted: 2025-10-06
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Study Start: 2025-11-01
• Primary Completion: 2026-11
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acid Acid Infusion	Amino Acid infusion	Amino Acid Infusion for up to 72 hours
Placebo Infusion	Lactated ringers solution	Placebo Infusion for up to 72 hours

Primary Outcome Measures

Name	Time	Method
Rate of acute kidney injury on post-operative days 2, 3, or 4	From enrollment to post-operative day 4	The rate of participants randomized to the amino acid infusion developing acute kidney injury as defined by Kidney Disease Improving Global Outcomes (KDIGO) as Stage 1, 2, or 3 will be compared to the rate of acute kidney injury in the placebo group
Rate of mechanical ventilation at 96 hours post-operatively	From enrollment to 96 hours post-operatively	Rate of participants randomized to the amino acid infusion needing invasive mechanical ventilation beyond 96 hours post-operatively from congenital cardiac surgery repair will be compared to the rate from the placebo group.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States