Using nitric oxide during heart surgery in newborns to prevent kidney injury

Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury

This study is testing if using nitric oxide during heart surgery can help newborns avoid kidney injury after their operation.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 1 Day to 31 Days
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT04216927 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of nitric oxide during cardiopulmonary bypass in neonates undergoing cardiac surgery for congenital heart disease. The study aims to determine if administering nitric oxide can reduce the incidence of acute kidney injury, a common complication affecting up to 60% of high-risk patients post-surgery. By targeting the inflammatory and coagulation pathways, the researchers hope to improve renal outcomes in this vulnerable population. The trial is interventional and is currently in Phase 3.

Who should consider this trial

Good fit: Ideal candidates for this study are neonates aged 31 days or younger who are scheduled for cardiac surgery involving cardiopulmonary bypass.

Not a fit: Patients with pre-existing kidney issues, major congenital anomalies, or those requiring emergency surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of acute kidney injury in neonates undergoing cardiac surgery.

How similar studies have performed: While the use of nitric oxide in similar contexts has shown promise, this specific approach in neonates undergoing cardiac surgery is novel and has not been widely tested.

Eligibility criteria

Inclusion Criteria:

* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Exclusion Criteria:

1. Failure to obtain informed consent from parent/guardian
2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
3. Emergency surgery,
4. Episode of cardiac arrest within 1 week before surgery,
5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
6. Use of inhaled NO (iNO) immediately prior to surgery,
7. Structural renal abnormalities by ultrasound,
8. Preoperative AKI,
9. Use of other investigational drugs,
10. Weight less than \<2 kg,
11. Gestational age \<36 weeks,
12. Major extracardiac congenital anomalies,
13. Non-English speakers.

Where this trial is running

Cincinnati, Ohio

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: David S Cooepr, MD

Conditions: AKI, CHD - Congenital Heart Disease, Surgery