Reoxygenation for Cyanotic Pediatric CHD

Study Overview
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Brief Summary
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Evidence is emerging that those patients with cyanotic pathologies may be more vulnerable to end-organ injury during and after surgery than those patients without, because of compromised cardiopulmonary performances or the proinflammatory state that follows conventional hyperoxic cardiopulmonary bypass. Several clinical and basic studies have identified that controlled oxygenation during the initiation of bypass significantly improved the cardiac adaptation and remodeling capacity than hyperoxic oxygenation strategy among cyanotic patients undergoing tetralogy of Fallot repair, as evidenced by these reduced myocardial gene expression profiles associated with reoxygenation injury. The investigators designed the reoxygenation for pediatric cardiac surgery study to investigate the effect of reoxygenation during cardiopulmonary bypass on clinical outcomes in patients with cyanotic congenital heart disease .

Official Title
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Reoxygenation Cardiopulmonary Bypass for Surgical Repair of Pediatric Cyanotic CHD

Conditions
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Tetralogy of Fallot

Intervention / Treatment
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* Procedure: Reoxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The operation-naive infants and young children aged 1 months to 18 years old were eligible for enrolment if they were indicated for undergoing anticipated radical repair of cyanotic congenital heart disease with cardiopulmonary bypass. Exclusion Criteria: The chromosomal defects, airway and parenchymal lung disease, immunodeficiency, blood transfusion during the current admission, previous cardiac operation, or the opinion of the treating physician that randomization would not be in the best interest of the patient (lack of equipoise)

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reoxygenation<br>After one minute of full bypass, fraction of inspired oxygen (FiO2) in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 40%-80% adjusted reoxygenation to maintain PO2 in the range of 250mm Hg-300 mm Hg or more during the bypass. | Procedure: Reoxygenation<br>* After one minute of full bypass, fraction of inspired oxygen (FiO2) in conservative group was increased at increments of 0.1 per minute to reach an FiO2 target of 40% that was adjusted to maintain an arterial PO2 in the range of 250 mm Hg or less during the bypass, while FiO2 in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 80% adjusted to maintain PO2 in the range of 300 mm Hg or more, on the basis of arterial PO2 level measured via a point of care blood gas analyzer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Logistic Organ Dysfunction (PELOD-2) score | the change in the updated Pediatric Logistic Organ Dysfunction (PELOD-2) score (PELOD-2 score; range, 0 to 33 points, with higher scores indicating more severe organ dysfunction) | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low cardiac output syndrome | Low cardiac output syndrome was defined as cardiac index < 2.2 L/min/m2 of BSA with central venous pressure >18 mmHg and mean arterial pressure < 50 mmHg. | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tetralogy of Fallot