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

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ClinicalTrials.gov Identifier: NCT02151877
Recruitment Status : Recruiting
First Posted : June 2, 2014
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Chawki Elzein, Advocate Health Care

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.


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)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass.
Study Start Date : July 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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
Drug: placebo
inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery
Other Name: control group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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..



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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
Contact: Chawki F Elzein, MD 7086843029 chawki.elzein@advocatehealth.com
Contact: Bonnie Hughes, RN,BSN 7086843772 bonnie.hughes@advocatehealth.com

Locations
United States, Illinois
Advocate Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Chawki F Elzein, MD    708-684-3029    chawki.elzein@advocatehealth.com   
Contact: Bonnie Hughes, BSN    7086843029    Bonnie.hughes@advocatehealth.com   
Sponsors and Collaborators
Chawki Elzein
Mallinckrodt
Investigators
Principal Investigator: Chawki F Elzein, MD Advocate Healthcare

Additional Information:
Responsible Party: Chawki Elzein, Associate clinical Professor, Advocate Health Care
ClinicalTrials.gov Identifier: NCT02151877     History of Changes
Other Study ID Numbers: K5900209
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chawki Elzein, Advocate Health Care:
Ischemia/reperfusion injury

Additional relevant MeSH terms:
Wounds and Injuries
Ischemia
Reperfusion Injury
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents