The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

NCT05838937 — Unknown, 100 participants, Semmelweis University Heart and Vascular Center

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Registry	NCT05838937, acronym MIX-ECMO
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Semmelweis University Heart and Vascular Center (Other); collaborators: I.Medizinische Klinik, Universitätsklinikum Mannheim, University Hospital, Limoges
Conditions	Echocardiography, Mechanical Circulatory Support, Myocardial Failure, Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication
Dates	start 2024-06-01 (estimated), primary completion 2025-06-01 (estimated), completion 2025-12-01 (estimated), first posted 2023-05-03, last updated 2024-04-18
Locations	1 site in Hungary

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Investigation cohort			Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 99 Years

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

+Locations (1)

Facility	City	Country	Status
Semmelweis University Heart and Vascular Center	Budapest, BP	Hungary