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

Cincinnati Children's Hospital Medical Center

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Acute Kidney Injury; Congenital Heart Disease

Treatments: Drug: gases Nitric Oxide (gNO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04259684

CIN001-gNO to prevent AKI

Details and patient eligibility

About

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.

Sex: All

Ages: Under 31 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

gNO Group

Experimental group

Description:

Participants in the treatment group will receive gNO added to the oxygenator gas flow at 20 ppm throughout the duration of cardiopulmonary bypass.

Treatment:

Drug: gases Nitric Oxide (gNO)

Control Group

No Intervention group

Description:

Participants in the control group will receive standard conduction of cardiopulmonary bypass.