About this trial
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 criteria
Qualifiers
All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Nitric Oxide
- Oxygen
Treatment groups
Sponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Mallinckrodt
Collaborator
Indiana University
Collaborator