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

NCT05101746 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: 211416
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are:

1. 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. 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. 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).

Conditions

Congenital Heart Disease; Congenital Heart Defect; Congenital Heart Malformations

Keywords

pediatric heart surgery; congenital heart surgery

Outcome Measures

Primary Outcomes (2)

• Level of glial fibrillary acid protein (GFAP)

  GFAP will be measured via blood sample

  baseline to peak rewarming temperature of blood (approximately 3 hours)

• Level of neutrophil gelatinase-associated lipocalin (NGAL)

  NGAL will be measured via blood sample

  baseline to 2 hours after CPB initiation (approximately 2 hours)

Secondary Outcomes (7)

• Daily prevalence of delirium as measured by preschool confusion assessment method for the ICU (psCAM-ICU)

  date of admission to date of discharge from ICU (approximately 14 days)

• Length of ICU stay

  date of admission to date of discharge from ICU (approximately 14 days)

• Duration of mechanical ventilation

  postoperative day 0 to hospital discharge (approximately 30 days)

• Length of hospital stay

  date of admission to date of hospital discharge (approximately 30 days)

• Mortality

  date of admission to date of hospital discharge and/or 90 days post operation (approximately 90 days)

Study Arms (2)

Nitric oxide group

EXPERIMENTAL

Participants in this group will receive Nitric Oxide (NO) while undergoing Cardiopulmonary bypass (CPB)

Drug: Nitric Oxide (NO) 20 part per million (ppm)

Standard of care cardiopulmonary bypass procedure

ACTIVE COMPARATOR

Participants in this group will receive standard of care

Other: Standard of care cardiopulmonary bypass

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).

Nitric oxide group

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).

Standard of care cardiopulmonary bypass procedure

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates and infants with CHD undergoing CPB for corrective surgery
• Age \<1 year old

You may not qualify if:

• Requirement of inhaled NO immediately prior to surgery
• Emergency surgery
• Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability) on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive status prior to critical illness
• Pre-existing renal disease

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• David P Bichell, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Pediatric Cardiac Surgery

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: November 1, 2021
• Study Start: April 25, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)