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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric oxide on CPB | Experimental | neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery |
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| control | Placebo Comparator | neonates not receiving inhaled NO into the cardiopulmonary bypass |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Nitric Oxide | Drug | delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | The primary study endpoints are to evaluate whether NO delivered through the neonatal cardiopulmonary bypass (CPB) circuit can decrease various biochemical markers of ischemia/reperfusion injury and oxidative damage. Markers to be analyzed will include cardiac troponin I, interleukins (IL), tumor necrosis factor, N-terminal prohormone for brain natriuretic peptide (NT-proBNP),lactate dehydrogenase (LDH), plasma anti-oxidant levels, plasma malondialdehyde (MDA) levels. | Pre-op baseline and up to 12 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fluid Balance at 48 Hours | The secondary study endpoints are to evaluate whether NO delivered through the neonatal CPB circuit can decrease the clinical signs of ischemia/reperfusion injury and/or cardiac dysfunction. Clinical parameters (post surgery) include inotropic support, fluid balances, diuretic support, ventilator times, and length of ICU stay will be evaluated. | 48 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Morbidity | 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.. | 1 month after cardiac surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chawki F Elzein, MD | Advocate Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
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| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitric Oxide on CPB | neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery Inhaled Nitric Oxide: delivered inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery 12 patients were enrolled prospectively over 4 years period |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2016 |
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| placebo | Drug | inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery |
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| Time Until Start of Diuretic Therapy | hours until start of diuretic therapy | Pre-op to 72 hours post surgery |
| Inotropic Score Day 1 | The Inotropic Score is an objective clinical tool used to quantify the need for cardiovascular support in children and adolescents after surgery and to predict prognosis of pediatric septic shock (higher score predicts higher risk or worse prognosis).The Inotropic Score is low if <= 20, intermediate if 21-30, and high if > 30. Formula used in the study: Daily inotropic score (mcg/kg/min) = Dopamine drip dose+ dobutamine drip dose+ (milrinone drip dose times 10) + (epinephrine drip dose times 100 ) | 24 hours post surgery |
| Length of Intubation and PSHU Stay | Days to extubation and Pediatric Surgical Heart Unit (PSHU) length of stay (LOS) as measuring patient surgical outcomes. | Surgery to discharge |
| Control |
neonates not receiving inhaled NO into the cardiopulmonary bypass placebo: inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery 12 patients were enrolled prospectively over 4 years period |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitric Oxide on CPB | neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery Inhaled Nitric Oxide: delivered inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery 12 patients were enrolled prospectively over 4 years period |
| BG001 | Control | neonates not receiving inhaled NO into the cardiopulmonary bypass placebo: inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery 12 patients were enrolled prospectively over 4 years period |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| anatomical diagnosis, hypoplastic left heart syndrome | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | The primary study endpoints are to evaluate whether NO delivered through the neonatal cardiopulmonary bypass (CPB) circuit can decrease various biochemical markers of ischemia/reperfusion injury and oxidative damage. Markers to be analyzed will include cardiac troponin I, interleukins (IL), tumor necrosis factor, N-terminal prohormone for brain natriuretic peptide (NT-proBNP),lactate dehydrogenase (LDH), plasma anti-oxidant levels, plasma malondialdehyde (MDA) levels. | Intent to treat (ITT) | Posted | Mean | Standard Deviation | ng/ml | Pre-op baseline and up to 12 hours after surgery |
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| Secondary | Total Fluid Balance at 48 Hours | The secondary study endpoints are to evaluate whether NO delivered through the neonatal CPB circuit can decrease the clinical signs of ischemia/reperfusion injury and/or cardiac dysfunction. Clinical parameters (post surgery) include inotropic support, fluid balances, diuretic support, ventilator times, and length of ICU stay will be evaluated. | Intent to treat | Posted | Median | Inter-Quartile Range | ml/kg | 48 hours post surgery |
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| Secondary | Time Until Start of Diuretic Therapy | hours until start of diuretic therapy | Intent to treat | Posted | Median | Inter-Quartile Range | hour | Pre-op to 72 hours post surgery |
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| Secondary | Inotropic Score Day 1 | The Inotropic Score is an objective clinical tool used to quantify the need for cardiovascular support in children and adolescents after surgery and to predict prognosis of pediatric septic shock (higher score predicts higher risk or worse prognosis).The Inotropic Score is low if <= 20, intermediate if 21-30, and high if > 30. Formula used in the study: Daily inotropic score (mcg/kg/min) = Dopamine drip dose+ dobutamine drip dose+ (milrinone drip dose times 10) + (epinephrine drip dose times 100 ) | ITT | Posted | Median | Inter-Quartile Range | mcg/kg/min | 24 hours post surgery |
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| Secondary | Length of Intubation and PSHU Stay | Days to extubation and Pediatric Surgical Heart Unit (PSHU) length of stay (LOS) as measuring patient surgical outcomes. | ITT | Posted | Median | Inter-Quartile Range | days | Surgery to discharge |
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| Other Pre-specified | Surgical Morbidity | 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.. | Intent to treat | Posted | Count of Participants | Participants | 1 month after cardiac surgery |
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Adverse events (AEs) were collected for the entire hospitalization period, from surgical date to 104 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitric Oxide on CPB | Group that received nitric oxide in CPB | 0 | 12 | 0 | 12 | 2 | 12 |
| EG001 | Control | Group that did not receive nitric oxide in CPB | 0 | 12 | 0 | 12 | 1 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chylothorax | Blood and lymphatic system disorders | Systematic Assessment | chylothorax |
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| needed cath intervention | Cardiac disorders | Systematic Assessment | developed narrowing at the proximal anastomosis of the Sano shunt, necessitating cardiac cath and stent implantation at the proximal Sano shunt |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chawki Elzein, MD, FACS | Advocate Health Care | 7086843029 | chawki.elzein@advocatehealth.com |
| Feb 4, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007511 | Ischemia |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| IL-8 change |
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| TNF alpha change |
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| NT pro-BNP change |
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| LDH change |
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| Superoxide Dismutase change |
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| Plasma MDA change |
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