The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Study Overview
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Brief Summary
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Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.

Detailed Description
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The study aims to examine the prognostic role of non-invasive myocardial work in veno-arterial extracorporeal membrane oxygenation therapy patients. Subjects with cardiogenic shock regardless of etiology will be enrolled 48-72 hours after the initiation of mechanical circulatory support. It is hypothesized that non-invasive myocardial work may be an independent prognosticator of the outcome.

Official Title
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The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Conditions
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Echocardiography, Mechanical Circulatory Support, Myocardial Failure, Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Investigation cohort<br>Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death from any cause during the study period | 30 days | 
| Need for renal replacement therapy | The total number of patients who need for renal replacement therapy during intensive care | 30 days | 
| Successful weaning from mechanical ventilation | The total number of patients who can be successfully weaned from invasive mechanical ventilation | 30 days | 
| Discharge from intensive care unit | The total number of patients who are discharged from intensive care unit | 30 days | 
| Discharge from hospital | The total number of patients who are discharged from hospital | 30 days | 
| Ventilator-free days | Days spent without invasive mechanical ventilation | 30 days | 
| VA-ECMO-free days | Days spent without VA-ECMO support | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial work index, Cardiogenic shock, Extracorporeal Membrane Oxygenation Therapy, Echocardiography