NO During CPB in Neonates to Reduce Risk of AKI

RECRUITING

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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:

🦠 AKI 🦠 CHD - Congenital Heart Disease 🦠 Surgery

🗓️ Study Start (Actual) 10 January 2023

🗓️ Primary Completion (Estimated) 31 December 2024

✅ Study Completion (Estimated) 1 June 2025

👥 Enrollment (Estimated) 40

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Cincinnati, Ohio, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 1 Day to 31 Days (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 4 December 2019
First Submitted that Met QC Criteria 31 December 2019
First Posted 3 January 2020

Study Record Updates

Last Update Submitted that Met QC Criteria 21 March 2024
Last Update Posted 22 March 2024
Last Verified March 2024