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Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass
Sponsor: Vanderbilt University Medical Center
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).
Official title: Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Effects on End Organ Damage to the Brain and Kidney
Key Details
Gender
All
Age Range
0 Years - 1 Year
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-04-25
Completion Date
2026-09
Last Updated
2025-10-08
Healthy Volunteers
No
Interventions
Nitric Oxide (NO) 20 part per million (ppm)
Nitric oxide will be mixed into the gas flow of the cardiopulmonary bypass (CPB) oxygenator, which will be kept at 1-3 L/min to allow for the desired NO delivery rate. NO levels will be maintained at 20ppm using a NO delivery system (INOmax, Mallinckrodt).
Standard of care cardiopulmonary bypass
Cardiopulmonary bypass (CPB) will be performed using the departmental guidelines and standards. CPB will be performed using in a nonpulsatile flow with the System 1 Heart Lung Machine (Terumo Cardiovascular Systems, Ann Arbor, Mich). The maximum perfusion flow will be 200 ml/kg/minute. Blood pressure management will be selected based on the patient age and procedure. Temperature management will be to cool the patient 32 celsius (C).
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States