Ischemic Postconditioning in Cardiac Surgery (IPICS)
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|ClinicalTrials.gov Identifier: NCT01813968|
Recruitment Status : Unknown
Verified October 2015 by Mari-Liis Kaljusto, Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : March 19, 2013
Last Update Posted : October 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery||Procedure: Ischemic postconditioning||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Ischemic Postconditioning in Cardiac Surgery|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||August 2016|
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
- 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 ]Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813968
|Contact: Mari-Liis Kaljusto, MD, PhD||22118080 ext +email@example.com|
|Contact: Jarle Vaage, MD, PhD||22118080 ext +firstname.lastname@example.org|
|Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål||Recruiting|
|Oslo, Norway, 0424|
|Principal Investigator: Mari-Liis Kaljusto, MD, PhD|