Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

Launched by XENIOS AG · Oct 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Synchronized Cardiac Support, which uses special equipment to help patients experiencing a severe condition known as cardiogenic shock. Cardiogenic shock happens when the heart cannot pump enough blood to meet the body's needs, often leading to very low blood pressure and symptoms like cold skin and reduced urine output. The trial will test how safe and effective this treatment is for patients who meet specific criteria.

To participate, individuals must be at least 18 years old and have signs of cardiogenic shock, such as low blood pressure that requires medication to stabilize. However, some people may not be eligible, including those who are pregnant, have recently participated in another clinical study, or are over 85 years old. The study is not yet recruiting participants, but once it starts, those who qualify will receive the new treatment and be monitored closely by healthcare professionals to see how well it works and if there are any side effects. This trial aims to improve treatment options for people in critical need of heart support.

Gender

ALL

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