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Purpose

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.

Conditions

Eligibility

Eligible Ages
Under 18 Years
Eligible 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Acid Acid Infusion 		Amino Acid Infusion for up to 72 hours
  • Drug: Amino Acid infusion
    Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours
    Other names:
    • Trophamine(TM) 10%
Placebo Comparator
Placebo Infusion 		Placebo Infusion for up to 72 hours
  • Drug: Lactated ringers solution
    Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day

Recruiting Locations

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Contact:
Clinical Research Manager
513-636-4837
kelli.krallman@cchmc.org

More Details

Status
Recruiting
Sponsor
Dana Fuhrman

Study Contact

Kelli Krallman, RN, BSN, MS
513-636-4837
kelli.krallman@cchmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.