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NCT Number: NCT07212595

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

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.

Recruiting

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mechanical Ventilation Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Clinical Research Manager

CONTACT

[email protected]

513-636-4837

Stuart Goldstein, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amino Acid infusion

Drug

Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours

Other names: Trophamine(TM) 10%

Lactated ringers solution

Drug

Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day

Primary outcomes

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

    Time frame: 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

  2. Rate of mechanical ventilation at 96 hours post-operatively

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelli Krallman, RN, BSN, MS

CONTACT

[email protected]

513-636-4837

Sponsors and collaborators

Lead sponsor

Dana Fuhrman

Other

Collaborators

  • Congenital Heart Alliance of Cincinnati

Registry information

Acronym: BRAVE-HEART

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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