Combined Use of a Novel Cardioplegic Formula With Myocardial Protection System (MPS)® Versus Cardioplexol ® in Isolated Coronary Artery Bypass Grafting (CABG) Using MiECC;

Study Overview
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Brief Summary
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Combined use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).

Official Title
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Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Isolated CABG Using MiECC (Minimal Extracorporeal Circulation System)

Conditions
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Complication of Extracorporeal Circulation, Complication of Coronary Artery Bypass Graft

Intervention / Treatment
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* Procedure: use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CABG using MPS® or Cardioplexol ® Exclusion Criteria: use of other colloid solution than Cardioplexol ® or MPS® other inventions than CABG myocardial infarction <7 days before CABG patients denial of data use
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardioplegia with MPS® (Myocardial protection system)<br>cardioplegic formula with MPS® (Myocardial protection system); use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation | Procedure: use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation<br>* use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).<br>|
| cardioplegia with Cardioplexol ®<br>cardioplegic formula with Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lab values for cardial biomarkers | cardial biomarkers measured are high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB) | perioperative during hospital stay for CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | death after coronary artery bypass grafting | 30 days after CABG | 
| need for intensive care unit | duration of stay at intensive care unit | perioperative during hospital stay for CABG | 
| dysrhythmia | rhythm disturbance after coronary artery bypass grafting | perioperative during hospital stay for CABG | 
| bleeding | bleeding complication after coronary artery bypass grafting | perioperative during hospital stay for CABG |