Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy

Study Overview
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Brief Summary
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Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution). This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.

Official Title
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Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy

Conditions
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Mitral Valve Reconstruction

Intervention / Treatment
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* Other: cardioplegia with HTK-Bretschneider cardioplegic solution
* Other: cardioplegia with St. Thomas cardioplegic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution). Exclusion Criteria: Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy done in cardioplegia with cardioplegic Solutions other than HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution).
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 |
| --- | --- |
| HTK-Bretschneider cardioplegic solution<br>Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with HTK-Bretschneider cardioplegic solution | Other: cardioplegia with HTK-Bretschneider cardioplegic solution<br>* cardioplegia with HTK-Bretschneider cardioplegic solution<br>|
| St. Thomas cardioplegic solution<br>Patients undergoing mitral valve reconstruction via minimal invasive antero- lateral thoracotomy in cardioplegia with St. Thomas cardioplegic solution | Other: cardioplegia with St. Thomas cardioplegic solution<br>* cardioplegia with St. Thomas cardioplegic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high specific troponin T (hs-TrT) (μg/l) | cardial biomarker for myocardial damage | perioperative during minimal invasive surgery | 
| Creatin-Phosphokinase (CK) (U/l) | cardial biomarker for myocardial damage | perioperative during minimal invasive surgery | 
| Creatinkinase Muscle- Brain (CK-MB) (U/l) | cardial biomarker for myocardial damage | perioperative during minimal invasive surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | number of deaths | from minimal invasive surgery until 30 days post surgery | 
| length of stay in intensive care unit (days) | length of stay in intensive care unit (number of days) | from minimal invasive surgery until 30 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral valve insufficiency, cardioplegia, cardioplegia Solution, HTK-Bretschneider (Custidiol®) solution, St. Thomas solution, cardiac biomarker