NO During CPB in Neonates to Reduce Risk of AKI

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-31
SponsorChildren's Hospital Medical Center, Cincinnati

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

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Mallinckrodt

Collaborator

Indiana University

Collaborator