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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05101746
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Congenital Heart Defect
  • Congenital Heart Disease
  • Congenital Heart Malformations

Eligibility Criteria

Sex
ALL
Age
0 Years - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Nitric Oxide (NO) 20 part per million (ppm) — DRUG
    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 — OTHER
    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).

Study Details

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).

Key Dates

Start date
Apr 25, 2022
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nitric oxide group
    Participants in this group will receive Nitric Oxide (NO) while undergoing Cardiopulmonary bypass (CPB)
  • Active Comparator: Standard of care cardiopulmonary bypass procedure
    Participants in this group will receive standard of care

Primary Outcome Measure

Level of glial fibrillary acid protein (GFAP) [ Time Frame: baseline to peak rewarming temperature of blood (approximately 3 hours) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212-

Find similar trials in Nashville, TN

By research site
Vanderbilt University Medical Center· Nashville, TN

Related Studies