Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-28 @ 6:53 PM
Study NCT ID:
NCT01813968
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2013-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic Postconditioning in Cardiac Surgery
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Ischemic Postconditioning in Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
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:
IPICS
Brief Summary:
Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.
Detailed Description:
Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients \> 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included.
The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.
The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: