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

Surgery AKI CHD - Congenital Heart Disease

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

Inclusion Criteria1

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

Exclusion Criteria13

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