Cardiogenic Shock, ECLS, Extracorporeal Membrane Oxygenation, VA ECMO
Conditions
Keywords
Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Synchronized Cardiac Support, ECLS, VA ECMO
Brief summary
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
Detailed description
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.
Interventions
DEVICESynchronized Cardiac Support with the icor kit
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).
Sponsors
Xenios AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent signed and dated by study patient/legal representative and investigator/authorised physician 2. Minimum age of 18 years 3. Patients in cardiogenic shock 4. Cardiogenic shock is defined as: 1. Systolic blood pressure \< 90 mmHg for at least 30 min 2. Inotropes and/or vasopressors are needed to maintain systolic blood pressure \> 90 mmHg 3. Clinical signs of heart insufficiency with pulmonary congestion 5. Signs of end organ hypoperfusion with at least one of the following criteria: 1. Cold, damp skin or extremities 2. Oliguria (≤ 30 mL/h) 6. Serum lactate \> 3.0 mmol/L
Exclusion criteria
1. In case of female patients: pregnancy or lactation period 2. Participation in an interventional clinical study during the preceding 30 days 3. Previous participation in the same study 4. Age \> 85 years 5. Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \> 30 min 6. No flow time \> 5 min 7. Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture) 8. Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.) 9. Fever (Body temperature \> 38.0 °C) or other evidence of sepsis 10. Onset of cardiogenic shock \> 6 h before enrolment 11. Lactate \> 16 mmol/L 12. Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters 13. Contra-indications for anticoagulation 14. Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiocirculatory stabilization and end-organ perfusion | up to 14 days | measured by the Change in Lactate Level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiocirculatory stabilization and end-organ perfusion | up to 14 days | measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload |
| Maintain gas exchange | up to 14 days | measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation |
| Maintain renal function | up to 14 days | measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF |
| Thermoregulation | up to 14 days | measured by the the Body Temperature |
| Extracorporeal Life Support (ECLS) Performance | up to 14 days | measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Variables | up to 14 days | 1. Severe adverse events, i.e. Hemolysis Bleeding 2. Severe adverse device events |
Countries
Germany
Contacts
Primary ContactAnja Derlet-Savoia, Dr.
Backup ContactCelina Erfle
Outcome results
None listed