NO During CPB in Neonates to Reduce Risk of AKI

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.

NCT Number	NCT04216927
Lead Sponsor	Children's Hospital Medical Center, Cincinnati Collaborators: Mallinckrodt, Indiana University
Conditions	AKI, CHD - Congenital Heart Disease, Surgery
Enrollment	40 participants
Start Date	2023-01-10
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-05