Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-29 @ 3:39 AM
Study NCT ID:
NCT07212595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
Sponsor:
Stuart Goldstein, MD
Organization:
Study Overview
Official Title:
Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAVE-HEART
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: