Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amino Acid infusion, Lactated ringers solution.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Mechanical Ventilation. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- Rate of acute kidney injury on post-operative days 2, 3, or 4 [Time frame: From enrollment to post-operative day 4]
- Rate of mechanical ventilation at 96 hours post-operatively [Time frame: From enrollment to 96 hours post-operatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT07212595 · 001 - BRAVE-HEART