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NCT02151877 · ClinicalTrials.gov registry record · NA
Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
A NA study of Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery and Inflammatory Reaction After Neonatal Cardiac Surgery, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02151877 is a NA study of Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery and Inflammatory Reaction After Neonatal Cardiac Surgery that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02151877, a NA study of Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery and Inflammatory Reaction After Neonatal Cardiac Surgery, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Inhaled Nitric Oxide
Study Locations (1)
Illinois
- Advocate Children's Hospital - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-07 |
| Est. Completion | 2018-08-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02151877
The ClinicalTrials.gov registry entry for NCT02151877 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT02151877 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT02151877 about?
NCT02151877 is a clinical study titled "Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass". 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 compl...
What is the current status of trial NCT02151877?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2014-07. Estimated completion is 2018-08-15.
What conditions does trial NCT02151877 study?
This clinical trial studies the following conditions: Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery, Inflammatory Reaction After Neonatal Cardiac Surgery.
What interventions are being tested in trial NCT02151877?
The interventions under investigation include: placebo (DRUG), Inhaled Nitric Oxide (DRUG).
Who is sponsoring clinical trial NCT02151877?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02151877 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery
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Inflammatory Reaction After Neonatal Cardiac Surgery
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Illinois
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