The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Echocardiography
- Sponsor
- Semmelweis University Heart and Vascular Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.
Detailed Description
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.
Investigators
Balint Karoly Lakatos
Assistant Professor
Semmelweis University Heart and Vascular Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation
Time Frame: 30 days
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
Secondary Outcomes
- Successful weaning from mechanical ventilation(30 days)
- Discharge from hospital(30 days)
- Need for renal replacement therapy(30 days)
- Ventilator-free days(30 days)
- All-cause mortality(30 days)
- Discharge from intensive care unit(30 days)
- VA-ECMO-free days(30 days)