Cardiac Surgery
Conditions
Keywords
Ischemic postconditioning, Adult cardiac surgery, Aortic valve surgery, Swan-Ganz, Cardiac index
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.
Interventions
PROCEDUREIschemic postconditioning
Sponsors
Medical University of Warsaw
University Hospital of North Norway
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac index between the groups during the first postoperative day | The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively | Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively |
Countries
Norway
Outcome results
None listed