drugset / Trial / NCT05101746

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

NCT05101746

Phase 2/3 Enrolling by invitation 50 enrolled Vanderbilt University Medical Center
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2022-04-25
Primary completion
2026-09
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 20 ppm Other