Ischemic Postconditioning in Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Surgery
- Sponsor
- Oslo University Hospital
- Enrollment
- 209
- Locations
- 1
- Primary Endpoint
- Change in cardiac index between the groups during the first postoperative day
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Mari-Liis Kaljusto
MD, PhD
Oslo University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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