Clinical trial NCT05838937: The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
Official title: The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Echocardiography
Mechanical Circulatory Support
Myocardial Failure
Cardiogenic Shock
Extracorporeal Membrane Oxygenation Complication
Keywords: Echocardiography
Myocardial work index
Cardiogenic shock
Extracorporeal Membrane Oxygenation Therapy
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: I.Medizinische Klinik, Universitätsklinikum Mannheim
name: University Hospital, Limoges
First posted: 2023-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Altogether 100 cardiogenic shock patients receiving veno-arterial extracorporeal membrane oxygenation therapy will be enrolled regardless the etiology. Both peripherially and centrally cannulated patients are eligible. Considering that the two populations are typically quite different in terms of indication for the therapy (ACS- or decompensated chronic heart failure-associated CS vs. cardiac surgery population), a balanced enrollment of the two methods will be facilitated. All LV venting options are eligible for enrollment, however, if utilized, the mode of LV unloading (central left atrial vent, Impella, transaortic LV pigtail catheter etc.) will also be collected.

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.

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

Primary outcomes:
measure: Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days
measure: Need for renal replacement therapy
timeFrame: 30 days
measure: Successful weaning from mechanical ventilation
timeFrame: 30 days
measure: Discharge from intensive care unit
timeFrame: 30 days
measure: Discharge from hospital
timeFrame: 30 days
measure: Ventilator-free days
timeFrame: 30 days
measure: VA-ECMO-free days
timeFrame: 30 days
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
state: BP
Study officials:
References: