- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813968
Ischemic Postconditioning in Cardiac Surgery (IPICS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mari-Liis Kaljusto, MD, PhD
- Phone Number: +47 22118080
- Email: m.l.kaljusto@gmail.com
Study Contact Backup
- Name: Jarle Vaage, MD, PhD
- Phone Number: +47 22118080
- Email: i.j.vaage@medisin.uio.no
Study Locations
-
-
-
Oslo, Norway, 0424
- Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients undergoing elective surgery of the ascending aorta or the aortic valve
-
Exclusion Criteria:
- Coronary artery disease requiring bypass surgery
- Tricuspid valve surgery
- Mitral valve surgery
- Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure)
- Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed)
- Patients with autoimmune diseases
- "Redo" operations
- Active endocarditis (ongoing antibiotic therapy)
- On the discretion of the operating surgeon or anaesthesiologist
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ischemic postconditioning
Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3
|
|
No Intervention: Control
Standard operating technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/2613
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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