Reoxygenation for Cyanotic Pediatric CHD

Nanjing Medical University

Status: Unknown

Conditions: Tetralogy of Fallot

Treatments: Procedure: Reoxygenation

Study type: Observational

Funder types: Other

Identifiers

NCT03568357

TedaICH-ROC

Details and patient eligibility

About

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 .

Enrollment: 500 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

500 participants in 1 patient group

Reoxygenation

Description:

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.

Treatment:

Procedure: Reoxygenation