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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery Inflammatory Reaction After Neonatal Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nitric oxide on CPB

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

Group Type EXPERIMENTAL

Inhaled Nitric Oxide

Intervention Type DRUG

delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery

control

neonates not receiving inhaled NO into the cardiopulmonary bypass

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery

Interventions

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Inhaled Nitric Oxide

delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery

Intervention Type DRUG

placebo

inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery

Intervention Type DRUG

Other Intervention Names

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study group control group

Eligibility Criteria

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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)

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No