Clinical trial NCT06766006: ECMO LEft Ventricle UNloading Strategy
Official title: A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shock, Cardiogenic
Cardiac Arrest
Extracorporeal Membrane Oxygenation Complication
Keywords: Extracorporeal Membrane Oxygenation
Left ventricle unloading
Cardiogenic shock
Cardiac Arrest
Mechanical Circulatory Supports
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: IRCCS Policlinico S. Donato
First posted: 2025-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by cardiogenic shock or cardiac arrest independent of etiology supported with VA ECLS.

Brief summary: The present study is an International multicentric prospective observational cohort study. This will be an international research campaign to prospectively collect and analyze clinical data of all VA ECLS patients admitted to participating ICUs with a focus on LV venting modalities. The aims of the study are:

* To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support;
* To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort.
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;

Detailed description: Cardiogenic shock and cardiac arrest are among the most lethal manifestations of acute cardiovascular disease, both burdened by extremely high in-hospital mortality rates. Extracorporeal life support is increasingly used either in adults or children with acutely impaired cardiac function refractory to conventional medical management, mainly in profound cardiogenic shock and refractory cardiac arrest. Veno-arterial extracorporeal life support works as a partial cardiopulmonary bypass draining the venous circulation directly into the systemic circulation. Veno-arterial extracorporeal life support provides biventricular support and provides respiratory gas exchange. One of the most important issues occurring during veno-arterial extracorporeal life support is the effect of the retrograde aortic flow which causes a marked increase in the left ventricular afterload with detrimental effects on myocardial performance. Left ventricular overload increases wall stress and myocardial oxygen consumption, jeopardizing ventricular recovery. Nowadays, different techniques are available for unloading the left chambers. However, despite the increasing worldwide experience with extracorporeal life support and the increased knowledge on the benefits of left ventricular unloading, the best veno-arterial extracorporeal life support configuration to achieve hemodynamic support, myocardial recovery, and left ventricular unloading, is still a matter of debate.

This is a prospective clinical study which is observational. The aims of the study are:

* To extensively describe the left ventricular unloading strategy during veno-arterial extracorporeal life support in a large prospective international cohort, providing detailed information on indications, timing, type and modality among a wide spectrum of clinical conditions
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes
* To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.

Demographics, clinical, instrumental and laboratory data prior and post implantation of veno-arterial extracorporeal life support will be collected. No interventions on top on the ones necessary as a standard of care will be taken.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing VA ECLS will be enrolled.

Exclusion Criteria:

* Patients without VA ECMO will not be considered

Primary outcomes:
measure: In-hospital mortality
timeFrame: Day 30
measure: Overload detection, Echocardiographic parameters
timeFrame: Within 12 hours before the applied unloading technique
measure: Unloading effectiveness, Echocardiographic parameters
timeFrame: 12 hours after the unloading technique implementation
Secondary outcomes:
measure: Unloading Effectiveness, Qualitative echocardiographic parameters
timeFrame: 12 hours after the unloading technique implementation
measure: Major adverse events
timeFrame: Day 30
measure: Left Ventricular functional status
timeFrame: Day 30
measure: LVAD Implementation
timeFrame: Day 30
measure: Heart transplant
timeFrame: Day 30
measure: Neurological status at discharge
timeFrame: Day 30
Other outcomes:
measure: Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic diameter (mm)
timeFrame: 12 hours after the unloading technique implementation
measure: Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic volume (ml)
timeFrame: 12 hours after the unloading technique implementation
measure: Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic diameter (mm)
timeFrame: 12 hours after the unloading technique implementation
measure: Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic volume(ml)
timeFrame: 12 hours after the unloading technique implementation
measure: Unloading Effectiveness, Quantitative echocardiographic parameters, LA volume (ml)
timeFrame: 12 hours after the unloading technique implementation
measure: Unloading Effectiveness, Quantitative echocardiographic parameters, E/E' septal and lateral (ratio, no unit of measurement )
timeFrame: 12 hours after the unloading technique implementation
measure: Unloading Effectiveness, Quantitative echocardiographic parameters, Systolic pulmonary artery pressure (mmHg)
timeFrame: 12 hours after the unloading technique implementation
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
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