RecruitingPhase 3NCT04216927

NO During CPB in Neonates to Reduce Risk of AKI

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

40 participants

Start Date

Jan 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 DayMax Age: 31 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nitric Oxide and a drug called Oxygen for people with aki, chd - congenital heart disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 1 Day to 31 Days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNitric Oxide

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

DRUGOxygen

Oxygen alone will be entrained for placebo arm


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT04216927


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