Cardiogenic Shock Clinical Trial
— MIX-ECMOOfficial title:
The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - 18 years or older age - Severe cardiogenic shock requiring the initiation of VA-ECMO therapy - Stabile hemodynamic state and oxigenation with VA-ECMO and vasoactive support - Informed written consent (due to the nature of the study, from a legally eligible relative of the patient) Exclusion Criteria: - Younger than 18 years of age - Unstable hemodynamic state or suboptimal oxigenation despite established VA-ECMO and vasoactive support - Severe neurological damage or confirmed brain death at the time of enrollment which squarely indicates therapy limitation and poor short-term outcome - Transesophageal echocardiography is contraindicated - Suboptimal echocardiographic window |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University Heart and Vascular Center | Budapest | BP |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University Heart and Vascular Center | I.Medizinische Klinik, Universitätsklinikum Mannheim, University Hospital, Limoges |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation | The total number of patients who die from cardiovascular cause, or require for transition to long-term mechanical circulatory support (LVAD/BiVAD), or heart transplantation | 30 days | |
Secondary | All-cause mortality | Death from any cause during the study period | 30 days | |
Secondary | Need for renal replacement therapy | The total number of patients who need for renal replacement therapy during intensive care | 30 days | |
Secondary | Successful weaning from mechanical ventilation | The total number of patients who can be successfully weaned from invasive mechanical ventilation | 30 days | |
Secondary | Discharge from intensive care unit | The total number of patients who are discharged from intensive care unit | 30 days | |
Secondary | Discharge from hospital | The total number of patients who are discharged from hospital | 30 days | |
Secondary | Ventilator-free days | Days spent without invasive mechanical ventilation | 30 days | |
Secondary | VA-ECMO-free days | Days spent without VA-ECMO support | 30 days |
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