NCT03568357

Reoxygenation for Cyanotic Pediatric CHD

Reoxygenation Cardiopulmonary Bypass for Surgical Repair of Pediatric Cyanotic CHD

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Tetralogy of Fallot

Interventions

Type	Name	Description
PROCEDURE	Reoxygenation	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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-06-26
• Last updated: 2018-06-26

Locations

1 site across 1 country: China