Coronary Artery Bypass Surgery, Valve Surgery
Conditions
Keywords
Cardioplegic Solutions
Brief summary
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.
Interventions
Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
Sponsors
Swiss Cardio Technologies AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients between 18 and 80 years of age; * The patient's pre-operative evaluation indicates the need for a primary elective cardiac coronary artery bypass graft (CABG) operation and/or a cardiac valve repair/replacement; * The operation can be carried out via a full sternotomy, under cardiac arrest and under the assistance of a heart lung machine; * Patients who provide signed written informed consent.
Exclusion criteria
* Pre-operative EF of less than 30%; * Pre-operative IABP; * Pre-operative catecholamine support; * History of myocardial infarction within less than 7 days; * Previous history of cardiac surgery, including the implantation of a pace maker or an ICD; * Active myocarditis and/or endocarditis; * Aortic valve insufficiency severity grade more than 1; * Under dialysis; * Pre-operative serum creatinine value of more than 2.0 mg/dl; * Known hematologic disorder; * Treatment with anti-vitamin K; * History of HIT; * Participating in a concomitant research study of an investigational product; * Pregnant or lactating; * Intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Deviation in Cardioplexol application | During surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CK-MB Values | During the first 24 hours following myocardial reperfusion | Development of concentration of blood Creatin Kinase - isoenzyme MB (muscle-brain) values measured by the local hospital laboratory |
| Complete Cardiac Arrest | During Surgery | Time between the aortic cross-clamping and the complete cardiac arrest |
| Catecholamine | During during aortic cross-clamping and during the first 24 hours | Cumulative dose of catecholamines |
| TnT Values | During the first 24 hours following myocardial reperfusion | Development of concentration of blood Troponin T values measured by the local hospital laboratory |
| ICU stay | During follow-up phase after surgery up to 35 days | Duration of ICU stay |
| Mortality | During the first 24 hours following coronary reperfusion | Number of patients, who died |
| Defibrillation rate | During surgery | Defibrillation rate after aorta unclamping and coronary reperfusion. |
Countries
Austria, Germany
Outcome results
None listed