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RECRUITING
NCT04216927
PHASE3

NO During CPB in Neonates to Reduce Risk of AKI

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

Official title: Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury

Key Details

Gender

All

Age Range

1 Day - 31 Days

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-01-10

Completion Date

2026-06-30

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DRUG

Nitric Oxide

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

DRUG

Oxygen

Oxygen alone will be entrained for placebo arm

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States