Actively Recruiting
NO During CPB in Neonates to Reduce Risk of AKI
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-07-24
40
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
M
Mallinckrodt
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
NO During CPB in Neonates to Reduce Risk of AKI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates 31 days old or younger undergoing cardiac surgery with cardiopulmonary bypass for congenital heart defects
You will not qualify if you...
- Failure to obtain informed consent from parent or guardian
- Clinical signs of persistent elevated pulmonary vascular resistance before surgery
- Emergency surgery
- Cardiac arrest episode within 1 week before surgery
- Recent steroid treatment or condition requiring steroids (except steroids given during cardiopulmonary bypass)
- Use of inhaled nitric oxide immediately before surgery
- Structural kidney abnormalities seen on ultrasound
- Acute kidney injury before surgery
- Use of other investigational drugs
- Weight less than 2 kg
- Gestational age less than 36 weeks
- Major extracardiac congenital anomalies
- Non-English speakers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
D
David S Cooepr, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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