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

StatusEnrolling by Invitation
PhasePhase 2/3
Started2022-04-25
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 8, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-10-06
Study Status v5
Primary completion date2025-08→2026-09
Completion date2025-08→2026-09
2024-08-13
Study Status v4
Primary completion date2024-11→2025-08
Completion date2024-11→2025-08
2023-07-14
Study Status v3
Re-verified, no change to tracked fields
2022-04-25
Study Status v2
Start dateestimated 2022-03-01→confirmed 2022-04-25
2022-03-09
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Primary completion date2022-11→2024-11
Completion date2022-11→2024-11
Start date2021-12-01→2022-03-01
Study sitescontacts updated at 1 of 1 site
2021-10-29
Original filing
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).
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