The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05838937

Acronym

MIX-ECMO

Enrollment

100

Registered

2023-05-03

Start date

2024-06-01

Completion date

2025-12-01

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Echocardiography, Myocardial work index, Cardiogenic shock, Extracorporeal Membrane Oxygenation Therapy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
All-cause mortality	30 days	Death from any cause during the study period
Ventilator-free days	30 days	Days spent without invasive mechanical ventilation
VA-ECMO-free days	30 days	Days spent without VA-ECMO support
Discharge from hospital	30 days	The total number of patients who are discharged from hospital

Countries

Hungary

Contacts

Primary ContactBálint K Lakatos, MD, PhD

lakatos.balint@med.semmelweis-univ.hu+36306663540

Outcome results