Acute Kidney Injury, Mechanical Ventilation
Conditions
Keywords
Cardiac Bypass, Pediatric, Acute Kidney Injury, Amino Acids
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.
Interventions
Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours
Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day
Sponsors
Stuart Goldstein, MD
Congenital Heart Alliance of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTKelli Krallman, RN, BSN, MS
PRINCIPAL_INVESTIGATORStuart Goldstein, MD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed