Reoxygenation for Cyanotic Pediatric CHD

• Conditions: Tetralogy of Fallot
• Interventions: Procedure: Reoxygenation

• Registration Number: NCT03568357
• Lead Sponsor: Nanjing Medical University

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2017-12-24
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-22
• Last Update Submitted: 2018-06-22
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reoxygenation	Reoxygenation	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.

Primary Outcome Measures

Name	Time	Method
Pediatric Logistic Organ Dysfunction (PELOD-2) score	up to 30 days	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)

Secondary Outcome Measures

Name	Time	Method
low cardiac output syndrome	up to 30 days	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.

Trial Locations

Locations (1)

TEDA International Cardiovascular Hospital; 🇨🇳 Tianjin, Tianjin, China