Clinical Trial

Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass

Enrolling by Invitation Phase 2/3
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Summary
The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery. GFAP will be analyzed via an enzyme-linked immunosorbent assay (ELISA) kit. Patients will also be monitored post-operatively for delirium in the intensive care unit (ICU). 2. To evaluate the renal protective effect of nitric oxide by measuring neutrophil gelatinase-associated lipocalin (NGAL) before and after surgery. NGAL will also be analyzed via an ELISA kit. Patient creatinine will be monitored post-operatively. 3. To evaluate effect of nitric oxide on other ICU outcomes (invasive mechanical ventilation, days to extubation, ICU and hospital length of stay, and blood product administration).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-10-29; most recent amendment 2025-10-06.
Status change: Not Yet Recruiting → Enrolling by Invitation 2022-03-09
Trial Details
NCT Number NCT05101746
Lead Sponsor Vanderbilt University Medical Center
Conditions Congenital Heart Disease, Congenital Heart Defect, Congenital Heart Malformations
Enrollment 50 participants
Start Date 2022-04-25
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-10-08