Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass

Wake Forest University (WFU)

Status: Completed

Conditions: Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery; Inflammatory Reaction After Neonatal Cardiac Surgery

Treatments: Drug: Inhaled Nitric Oxide; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02151877

K5900209

Details and patient eligibility

About

Around 7500 neonates born yearly in the United States have complex congenital heart disease that require surgical repair in the first few days of life. The complexity of the surgical repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent periods of low flow or complete circulatory arrest. The immature neonatal vital organs are more prone to the complications of the cardiopulmonary bypass circulation, namely ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide (NO) is used frequently in neonates for the treatment of pulmonary hypertension, Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R injury and endothelial dysfunction.

The purpose of this pilot study is to assess the efficacy of NO administration via the CPB circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in neonates undergoing repair of complex congenital heart defects. Specific goals will be to demonstrate that NO use via CPB will:

• Decrease markers of I/R injury and systemic inflammatory response.
• Decrease platelet activation leading to reduced postoperative bleeding and transfusion requirements.
• Decrease postoperative organ dysfunction, and hence decrease operative mortality and postoperative morbidity.

Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the CPB circuit, for the duration of surgery. They will be compared to a control group of 12 similar patients. Serum levels of different ischemic reperfusion injury and inflammatory markers will be measured at different time points after surgery and will be correlated with different end organ function tests and clinical course in the postoperative period. The results will be compared between the two groups to try to determine the clinical benefit of NO administration through CPB circuit.

Enrollment: 24 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates, age 0-30 days
• Full term, > 37 weeks gestation
• Birth weight ≥ 2.6 kg

Exclusion criteria

• Preoperative sepsis
• Preoperative renal dysfunction
• Preoperative intracranial hemorrhage
• Chromosomal abnormalities and/or genetic syndromes
• Prior intervention (catheter based or surgical)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Nitric oxide on CPB

Experimental group

Description:

neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery

Treatment:

Drug: Inhaled Nitric Oxide

control

Placebo Comparator group

Description:

neonates not receiving inhaled NO into the cardiopulmonary bypass

Treatment:

Drug: placebo