Recruiting
Phase 3

NO

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT04216927

Conditions

AKI

CHD - Congenital Heart Disease

Surgery

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Nitric Oxide

Oxygen

Study Details

Brief summary:

Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.

Conditions

AKI

CHD - Congenital Heart Disease

Surgery

Study ID

NCT04216927

Start date

Jan 10, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Exclusion Criteria:

1. Failure to obtain informed consent from parent/guardian
2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
3. Emergency surgery,
4. Episode of cardiac arrest within 1 week before surgery,
5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
6. Use of inhaled NO (iNO) immediately prior to surgery,
7. Structural renal abnormalities by ultrasound,
8. Preoperative AKI,
9. Use of other investigational drugs,
10. Weight less than <2 kg,
11. Gestational age <36 weeks,
12. Major extracardiac congenital anomalies,
13. Non-English speakers.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Nitric Oxide

Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care

placebo comparator: Oxygen

Standard CPB without NO administered at any point intraoperatively

Interventions

Nitric Oxide

gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit

Oxygen

Oxygen alone will be entrained for placebo arm

Primary outcome measure

  • AKI [ Time Frame: 72 hours ]

Central Contacts and Locations

Central contacts

David S Cooepr, MD

5138035448David.Cooper@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

David S. Cooper, MD

5138035448David.Cooper@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-08-05.