Nitric Oxide During CPB to Reduce AKI in Neonates

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, randomized, double-blind, placebo-controlled pilot study to investigate whether supplemental Nitric Oxide (NO) gas delivered during cardiac surgery with cardiopulmonary bypass (CPB) reduces the incidence and impact of acute kidney injury (AKI) in neonates undergoing surgery for congenital heart disease (CHD), when compared to placebo gas

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fabio Savorgnan
• Collaborator: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Age:
• Gestational age: 38 weeks

• Diagnosis: Congenital Heart Disease (CHD)

• Planned surgery to include cardiopulmonary bypass (CPB )for underlying CHD

• Consent of parent/guardian

Exclusion Criteria:

• Currently receiving or has received inhaled nitric oxide (NO) or other nitrogen donors such as sildenafil or nitroprusside

• Pre-existing acute kidney injury (AKI) as per the AKIN criteria;

• Cardiac arrest within one week prior consent;

• Prior cardiac surgery with CPB procedure;

• Prior history of Extra Corporeal Membrane Oxygenation (ECMO)

• Use of another investigational drug.