The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Cardiogenic Shock Clinical Trial

— MIX-ECMO  

Official title:

The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05838937
• Other study ID #: BMEÜ/4229- 1 /2022/EKU
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Semmelweis University Heart and Vascular Center
• Contact: Bálint K Lakatos, MD, PhD
• Phone: +36306663540
• Email: lakatos.balint[@]med.semmelweis-univ.hu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Hungary	Semmelweis University Heart and Vascular Center	Budapest	BP

Sponsors (3)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center	I.Medizinische Klinik, Universitätsklinikum Mannheim, University Hospital, Limoges

Country where clinical trial is conducted

Hungary, 

Outcome

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