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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Stuart Goldstein, MD
Study ID
NCT07212595
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Mechanical Ventilation

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Amino Acid infusion — DRUG
    Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours
  • Lactated ringers solution — DRUG
    Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Acid Acid Infusion
    Amino Acid Infusion for up to 72 hours
  • Placebo Comparator: Placebo Infusion
    Placebo Infusion for up to 72 hours

Primary Outcome Measure

Rate of acute kidney injury on post-operative days 2, 3, or 4 [ Time Frame: From enrollment to post-operative day 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Clinical Research Manager
[email protected]
513-636-4837
Stuart Goldstein, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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