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Amino Acid Therapy for Kidney Protection After Pediatric Heart Surgery

This study, called BRAVE-HEART, is looking into whether an amino acid infusion can help protect children from acute kidney injury (sudden kidney damage) after heart surgery. Researchers want to see if giving an amino acid infusion for up to 72 hours can reduce the number of children who develop acute kidney injury and how long they need a ventilator (breathing machine). Children under 18 who weigh at least 5 kilograms and are at high risk for kidney injury after heart surgery may be eligible. Participants will receive either the amino acid infusion or a placebo (an inactive substance that looks the same). The study aims to enroll 30 participants.

Study design
This is an interventional study comparing an amino acid infusion to a placebo in 30 participants. It is not specified if participants or researchers will know which treatment is being given.
What's involved
Participants will receive an amino acid or placebo infusion for up to 72 hours, starting during heart surgery and continuing in the operating room or intensive care unit.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for acute kidney injury up to 4 days after surgery and for mechanical ventilation up to 96 hours (4 days) after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07212595

Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy

Recruiting
PHASE2Up to 18InterventionalPrevention
Dana Fuhrman
~30 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Amino Acid infusionLactated ringers solution

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of acute kidney injury on post-operative days 2, 3, or 4
Measured over From enrollment to post-operative day 4
+1 more outcome measured

Conditions

Acute Kidney Injury
Mechanical Ventilation

Explore related trials

Acute Renal FailureCardiac Surgery

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Stuart Goldstein, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Kelli Krallman, RN, BSN, MS
[email protected]
513-636-4837
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of acute kidney injury on post-operative days 2, 3, or 4From 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-operativelyFrom 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.