This is a multi-center, open label, single group, observational study designed to evaluate the effects of a Cardioplexol™ preparation and administration training program proposed to cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™. The training program aims at increasing the efficacy of Cardioplexol administration while reducing the risk of false manipulations. During the training possible risks and consequences of incorrect applications as well as the measures to take in case of administration error, are discussed. The training program includes one standardized theoretical part and one practical part consisting of a direct intra-operative coaching of surgeons practicing their first 2 operations. The effect of the training will then be assessed by evaluating each trained surgeon's 4 next consecutive patients operated with Cardioplexol and without the coach.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
171
Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
Universitätsklinik Innsbruck
Innsbruck, Austria
Universitaetsklinikum Salzburg
Salzburg, Austria
Universitaetsklnikum St. Pölten
Sankt Pölten, Austria
Krankenhaus Hietzing
Vienna, Austria
Deutsches Herzzentrum Berlin
Berlin, Germany
Universitaetsklinikum Frankfurt
Frankfurt, Germany
Major Deviation in Cardioplexol application
Number of major deviations from the application of Cardioplexol™ as determined by the pre-specified training documentation (incorrect volume of initial dose, incorrect volume of second/third/fourth dose, incorrect duration of injection of initial dose, incorrect timing of application of initial dose, incorrect timing of application of second/third/fourth dose).
Time frame: During surgery
TnT Values
Development of concentration of blood Troponin T values measured by the local hospital laboratory
Time frame: During the first 24 hours following myocardial reperfusion
CK-MB Values
Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory
Time frame: During the first 24 hours following myocardial reperfusion
Complete Cardiac Arrest
Time between the aortic cross-clamping and the complete cardiac arrest
Time frame: During Surgery
Catecholamine
Cumulative dose of catecholamines
Time frame: During during aortic cross-clamping and during the first 24 hours
Defibrillation rate
Defibrillation rate after aorta unclamping and coronary reperfusion.
Time frame: During surgery
ICU stay
Duration of ICU stay
Time frame: During follow-up phase after surgery up to 35 days
Mortality
Number of patients, who died
Time frame: During the first 24 hours following coronary reperfusion
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