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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Kelli Krallman, RN, BSN, MS
kelli.krallman@cchmc.org
513-636-4837
Time Frame
Start Date: 2026-07-08
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Acid Acid Infusion
Amino Acid Infusion for up to 72 hours
Placebo_comparator: Placebo Infusion
Placebo Infusion for up to 72 hours
Related Therapeutic Areas
Sponsors
Leads: Dana Fuhrman
Collaborators: Congenital Heart Alliance of Cincinnati

This content was sourced from clinicaltrials.gov