Clinical trial NCT05106491: Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
Official title: Evaluating the Efficacy and Safety of the Synchronized Cardiac Support Treatment with the Icor Kit in Patients with Cardiogenic Shock - a Pivotal Study (Pulse SE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Extracorporeal Membrane Oxygenation
ECLS
VA ECMO
Keywords: Cardiogenic Shock
Extracorporeal Membrane Oxygenation
Synchronized Cardiac Support
ECLS
VA ECMO
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiocirculatory stabilization and end-organ perfusion
timeFrame: up to 14 days
Secondary outcomes:
measure: Cardiocirculatory stabilization and end-organ perfusion
timeFrame: up to 14 days
measure: Maintain gas exchange
timeFrame: up to 14 days
measure: Extracorporeal Life Support (ECLS) Performance
timeFrame: up to 14 days
measure: Maintain renal function
timeFrame: up to 14 days
measure: Thermoregulation
timeFrame: up to 14 days
Other outcomes:
measure: Safety Variables
timeFrame: up to 14 days
Locations:
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz und Winsen gGmbH
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen GmbH
Study officials:
affiliation: Elisabeth-Krankenhaus Essen
name: Ingo Voigt, Dr.
role: PRINCIPAL_INVESTIGATOR
References: