Trials / Recruiting
RecruitingNCT04216927
NO During CPB in Neonates to Reduce Risk of AKI
Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 1 Day – 31 Days
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nitric Oxide | gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit |
| DRUG | Oxygen | Oxygen alone will be entrained for placebo arm |
Timeline
- Start date
- 2023-01-10
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2020-01-03
- Last updated
- 2025-07-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04216927. Inclusion in this directory is not an endorsement.