NO During CPB in Neonates to Reduce Risk of AKI
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: AKI, CHD - Congenital Heart Disease, Surgery
In brief
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.
Key facts
- Study ID
- NCT04216927
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 40
- Starts
- 2023-01-10
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-08-05
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
You may not qualify if…
- 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.
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.