ECMO LEft Ventricle UNloading Strategy

ConditionsShock, Cardiogenic Cardiac Arrest Extracorporeal Membrane Oxygenation Complication

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age1-80

SponsorMaastricht University Medical Center

About this trial

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;

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients undergoing VA ECLS will be enrolled.

Disqualifiers

Patients without VA ECMO will not be considered

Trial population

Patients affected by cardiogenic shock or cardiac arrest independent of etiology supported with VA ECLS.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Venoarterial extracorporeal life support (VA ECLS) implant
Procedure/Surgery
Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: VA ECLS patients1 intervention

Trial outcomes

Primary outcomes

In-hospital mortality

Death during hospital stay

Time frame

Day 30

Overload detection, Echocardiographic parameters

Presence of left ventricle (LV) overload (defined as: aortic valve opening impairment and/or smoke like effect and/or LA distension and/or LV distension). The aforementioned criteria are defined as follows: * Aortic valve opening impairment: Aortic valve does not open every beat. * Smoke like effect: spontaneous echo contrast inside left ventricle chamber. * Left Atrium (LA) distension: male/female LA volume/body surface area (BSA)\>=34 or increase\>15% * LV distension: LV end-diastolic volume (ml) \>150 ml, male; female LV end-diastolic volume (ml) \>106 ml or increase\>15%

Time frame

Within 12 hours before the applied unloading technique

Unloading effectiveness, Echocardiographic parameters

Echocardiographic qualitative parameters: * aortic valve opening (yes/no) * smoke like effect (yes/no) * LA distension (yes/no) * LV distension (yes/no) * inferior vena cava collapse/dilation (yes/no) * grade of mitral regurgitation (mild/moderatre/severe) Echocardiographic quantitative parameters: * LV end-diastolic diameter (mm) * LV end-diastolicvolume (ml) * LV end-systolic diameter (mm) * LV end-systolic volume(ml) * LA volume (ml) * E/E' septal and lateral (ratio, no unit of measurement ) * systolic pulmonary artery pressure (mmHg)

Time frame

12 hours after the unloading technique implementation

Secondary outcomes

Unloading Effectiveness, Qualitative echocardiographic parameters

Unloading effectiveness, qualitative evaluation (yes/no) ( any of the following criteria: restored aortic valve opening (yes/no) and/or solved smoke like effect (yes/no) and/or reduced LA distension (yes/no) and/or reduced LV distension (yes/no) and/or decreased grade of mitral regurgitation)

Time frame

12 hours after the unloading technique implementation

Major adverse events

Cerebral injury (stroke, transitory ischemic attack, intracranial hemorrhage and seizures by electroencephalogram), acute kidney injury requiring continuous renal replacement therapy, hemolysis (defined as increased free hemoglobin level, peripheral vascular damage, infections (defined as positive bacterial, fungal or viral culture or polymerase chain reaction test), coagulation disorders (either thrombosis or hemorrhage) and ECLS failure (pump or oxygenator failure, or both), liver and kidney organ function.

Time frame

Day 30

Left Ventricular functional status

Left ventricle Ejection fraction (%)

Time frame

Day 30

LVAD Implementation

LVAD implant

Time frame

Day 30

Other outcomes

Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic diameter (mm)

LV end-diastolic diameter (mm)

Time frame

12 hours after the unloading technique implementation

Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic volume (ml)

LV end-diastolic volume (ml)

Time frame

12 hours after the unloading technique implementation

Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic diameter (mm)

LV end-systolic diameter (mm)

Time frame

12 hours after the unloading technique implementation

Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic volume(ml)

LV end-systolic volume(ml)

Time frame

12 hours after the unloading technique implementation

Sponsors and contacts

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Maastricht University Medical Center

Lead sponsor

IRCCS Policlinico S. Donato

Collaborator

Source ClinicalTrials.gov

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