Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT03568357
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2017-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reoxygenation for Cyanotic Pediatric CHD
Sponsor:
Nanjing Medical University
Organization:
Study Overview
Official Title:
Reoxygenation Cardiopulmonary Bypass for Surgical Repair of Pediatric Cyanotic CHD
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reoxygenation
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 .
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: