The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4
The current study hypothesizes that The SCS treatment with the icor kit provides sufficient support for cardiocirculatory function as indicated by a significant lactate reduction 24 hours on SCS treatment versus before treatment start. Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support. Synchronized Cardiac Support describes an electrocardiogram (ECG)- triggered pulsatile VA-ECMO based on R-wave detection. During diastole the pump speed and thus the flow is increased and during systole the pump flow is been set on a relative minimum. This provides a mechanical circulatory support pulse with oxygenated blood during diastole. The Synchronized Cardiac Support Treatment is used in a standard VA ECMO configuration by two femoral single vessel cannulas. Patients following cardiac resuscitation will undergo targeted temperature management 32- 36°C according to guideline. The Duration of Treatment can be up to 14 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
21
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).
Krankenhaus Buchholz und Winsen gGmbH
Buchholz, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, Germany
Cardiocirculatory stabilization and end-organ perfusion
measured by the Change in Lactate Level
Time frame: up to 14 days
Cardiocirculatory stabilization and end-organ perfusion
measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload
Time frame: up to 14 days
Maintain gas exchange
measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation
Time frame: up to 14 days
Extracorporeal Life Support (ECLS) Performance
measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation
Time frame: up to 14 days
Maintain renal function
measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF
Time frame: up to 14 days
Thermoregulation
measured by the the Body Temperature
Time frame: up to 14 days
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