Ischemic Postconditioning in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ischemic Postconditioning in Cardiac Surgery

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Procedure: Ischemic postconditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ischemic postconditioning<br>Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of ischemia x 3 | Procedure: Ischemic postconditioning<br> <br> |
| No Intervention: Control<br>Standard operating technique | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac index between the groups during the first postoperative day | Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively | The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Swan-Ganz, Ischemic postconditioning, Adult cardiac surgery, Aortic valve surgery, Cardiac index