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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization | Other | Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synchronized Cardiac Support with the icor kit | Device | Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS). |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiocirculatory stabilization and end-organ perfusion | measured by the Change in Lactate Level | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiocirculatory stabilization and end-organ perfusion | measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload | up to 14 days |
| Maintain gas exchange |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Variables |
| up to 14 days |
Inclusion Criteria:
Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
Minimum age of 18 years
Patients in cardiogenic shock
Cardiogenic shock is defined as:
Signs of end organ hypoperfusion with at least one of the following criteria:
Serum lactate > 3.0 mmol/L
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anja Derlet-Savoia, Dr. | Contact | +49 6172 2686648 | anja.derlet@freseniusmedicalcare.com | |
| Celina Erfle | Contact | +49 6172 2686809 | celina.erfle@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Ingo Voigt, Dr. | Elisabeth-Krankenhaus Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Buchholz und Winsen gGmbH | Buchholz | 21244 | Germany |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation
| 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 | up to 14 days |
| Maintain renal function | measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF | up to 14 days |
| Thermoregulation | measured by the the Body Temperature | up to 14 days |
| Elisabeth-Krankenhaus Essen GmbH | Essen | 45138 | Germany |
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |