Nitric Oxide During Cardiopulmonary Bypass in Neonates to Reduce Risk of Acute Kidney Injury

• Status: Withdrawn
• Trial end date: 2019-10-20
• Target enrollment: 0
• Participant gender: All

Summary

Acute kidney injury following cardiac surgery for congenital heart defects in children is a major cause of both short- and long-term morbidity and mortality, affecting up to 60% of high risk patients. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Based on preliminary data available in the literature, we hypothesize that nitric oxide (gNO), administered during cardiopulmonary bypass (CPB), may reduce the risk of acute kidney injury (AKI) via mechanisms of reduced inflammation and vasodilation. In this pilot study, 40 neonates undergoing cardiac surgery will be randomized to receive intraoperative administration of 20 ppm of nitric oxide to the oxygenator of the cardiopulmonary bypass circuit or standard CPB with no additional gas.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Neonates (≤31 days) undergoing cardiac surgery with cardiopulmonary bypass for congenital heart disease

Exclusion Criteria:

• 1. Failure to obtain informed consent from parent/guardian,

• Clinical signs of preoperative persistent elevated pulmonary vascular resistance,

• Emergency surgery,

• Episode of cardiac arrest within 1 week before surgery,

• Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),

• Use of inhaled NO (iNO) immediately prior to surgery,

• Structural renal abnormalities by ultrasound,

• Preoperative AKI,

• Use of other investigational drugs,

• Weight less than <2.2 kg,

• Gestational age <36 weeks,

• Major extracardiac congenital anomalies.