Ischemic Postconditioning in Cardiac Surgery (IPICS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Ischemic Postconditioning in Cardiac Surgery|
- Change in cardiac index between the groups during the first postoperative day [ Time Frame: The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively ] [ Designated as safety issue: No ]Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Ischemic postconditioning
Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3
|Procedure: Ischemic postconditioning|
No Intervention: Control
Standard operating technique
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813968
|Contact: Mari-Liis Kaljusto, MD, PhD||22118080 ext +firstname.lastname@example.org|
|Contact: Jarle Vaage, MD, PhD||22118080 ext +email@example.com|
|Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål||Recruiting|
|Oslo, Norway, 0424|
|Principal Investigator: Mari-Liis Kaljusto, MD, PhD|