NO During CPB in Neonates to Reduce Risk of AKI
Key facts
- Where
- Cincinnati, United StatesSee the site
- Phase
- Phase 3
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: David S. Cooper, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Trial code
- NCT04216927
- Record updated
- 5 August 2026
- Original description
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.Read full original descriptionShow less
Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury
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.
Inclusion: All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
Exclusion: 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,; Use of other investigational drugs,; Failure to obtain informed consent from parent/guardian; Gestational age <36 weeks,; Clinical signs of preoperative persistent elevated pulmonary vascular resistance,; Structural renal abnormalities by ultrasound,; Preoperative AKI,; Weight less than <2 kg,; Major extracardiac congenital anomalies,; Non-English speakers.