Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of acute kidney injury on post-operative days 2, 3, or 4
Study Overview
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:
- Does an amino acid infusion decrease the number of participants with acute kidney injury?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo Infusion
Placebo Infusion for up to 72 hours
Intervention: Lactated ringers solution (Drug)
Acid Acid Infusion
Amino Acid Infusion for up to 72 hours
Intervention: Amino Acid infusion (Drug)
Outcomes
Primary Outcomes
Rate of acute kidney injury on post-operative days 2, 3, or 4
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dana Fuhrman
Associate Director, Center for Acute Care Nephrology
Children's Hospital Medical Center, Cincinnati