Amino acid infusion after heart surgery to protect kids’ kidneys

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In BRAVE-HEART, children up to 18 years old undergoing cardiac surgery are randomized to receive either an amino acid infusion or a placebo for up to 72 hours in the operating room and ICU. The trial compares how often acute kidney injury occurs and how many days patients need ventilator support between the two groups. Treatments include amino acid infusions and lactated Ringer’s solution as a control. The study aims to identify whether amino acids can protect kidney function and improve recovery after surgery in a high-risk pediatric population.

Why it matters

Who can join: the full rules

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

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Stuart Goldstein, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Kelli Krallman, RN, BSN, MS
• Email: kelli.krallman@cchmc.org
• Phone: 513-636-4837

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.