Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
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|ClinicalTrials.gov Identifier: NCT02151877|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : August 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery Inflammatory Reaction After Neonatal Cardiac Surgery||Drug: Inhaled Nitric Oxide Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||August 15, 2018|
|Actual Study Completion Date :||August 15, 2018|
Experimental: Nitric oxide on CPB
neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery
Drug: Inhaled Nitric Oxide
delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery
Other Name: study group
Placebo Comparator: control
neonates not receiving inhaled NO into the cardiopulmonary bypass
inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery
Other Name: control group
- inflammatory biomarkers [ Time Frame: 48 hours after cardiac surgery ]Markers of ischemia/reperfusion injury (PLasma Malondialdehyde (MDA), superoxide Dismutase, Neurotrophin (NT) pro-B-natriuretic peptide (BNP)..) and inflammatory markers (Interleukins 6 and 8, Procalcitonin, Tumor necrosis factor TNF alpha..) will be measured at different time intervals after cardiac surgery and compared between study group and control group.
- Fluid balance [ Time Frame: 48 hours after cardiac surgery ]The total fluid requirements and diuretic needs will be evaluated, as well as the length of time (days) needed to diurese all the extra fluids that accumulated after cardiac surgery.
- Surgical morbidity [ Time Frame: 1 month after cardiac surgery ]include all complications that may happen after cardiac surgery for the whole period of hospital stay, that is expected to be around 1 month. This include renal failure, prolonged intubation and ventilatory support, infections..
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151877
|United States, Illinois|
|Advocate Children's Hospital|
|Oak Lawn, Illinois, United States, 60453|
|Principal Investigator:||Chawki F Elzein, MD||Advocate Healthcare|