Clinical trial NCT02151877: Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
Official title: Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery
Inflammatory Reaction After Neonatal Cardiac Surgery
Keywords: Ischemia/reperfusion injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2014-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op)
timeFrame: Pre-op baseline and up to 12 hours after surgery
Secondary outcomes:
measure: Total Fluid Balance at 48 Hours
timeFrame: 48 hours post surgery
measure: Time Until Start of Diuretic Therapy
timeFrame: Pre-op to 72 hours post surgery
measure: Inotropic Score Day 1
timeFrame: 24 hours post surgery
measure: Length of Intubation and PSHU Stay
timeFrame: Surgery to discharge
Other outcomes:
measure: Surgical Morbidity
timeFrame: 1 month after cardiac surgery
Locations:
city: Oak Lawn
country: United States
facility: Advocate Children's Hospital
state: Illinois
Study officials:
affiliation: Advocate Healthcare
name: Chawki F Elzein, MD
role: PRINCIPAL_INVESTIGATOR
References: