The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Not yet recruiting

• Conditions: Echocardiography; Mechanical Circulatory Support; Extracorporeal Membrane Oxygenation Complication; Myocardial Failure; Cardiogenic Shock

• Registration Number: NCT05838937
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-05-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation	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 Outcome Measures

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

Trial Locations

Locations (1)

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, BP, Hungary