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

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 25, 2022

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Congenital Heart DiseaseCongenital Heart DefectCongenital Heart Malformations
Interventions
DRUG

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).

OTHER

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).

Trial Locations (1)

37212

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER