Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorDana Fuhrman
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Preoperative extracorporeal organ support
History of chronic kidney disease
Known or suspected inborn errors of amino acid metabolism
Known hypersensitivity to amino acids
Trial design
Design model
Parallel
Treatments tested in this trial
Amino Acid infusion
DrugAmino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours
Lactated ringers solution
DrugPlacebo infusion to match the volume of the amino acid infusion in grams/kilogram/day
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Acid Acid InfusionExperimental treatment 1 intervention
Group B: Placebo InfusionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of acute kidney injury on post-operative days 2, 3, or 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
Time frame
From enrollment to post-operative day 42
Rate of mechanical ventilation at 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.
Time frame
From enrollment to 96 hours post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana Fuhrman
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Sponsor institution
Congenital Heart Alliance of Cincinnati
Collaborator
Source ClinicalTrials.gov