drugset / Trial / NCT04216927
NO During CPB in Neonates to Reduce Risk of AKI
Phase 3
Recruiting
40 enrolled
Children's Hospital Medical Center, Cincinnati
Indiana University · collabMallinckrodt · collab
RandomizedSequentialTriple-blindPrevention
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.
Timeline
- Start
- 2023-01-10
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitric Oxide | Other / unclassified | 20 ppm | Other |