ECMO LEft Ventricle UNloading Strategy (ECMOLENS)

January 3, 2025 updated by: Maastricht University Medical Center

A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support

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;

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • All patients undergoing VA ECLS will be enrolled.

Exclusion Criteria:

  • Patients without VA ECMO will not be considered

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VA ECLS patients
All patients undergoing VA ECLS will be enrolled. Patients without VA ECLS will not be considered. Centers will follow their standard protocols for the management of patients on VA ECLS.
Procedure: Venoarterial extracorporeal life support (VA ECLS) implant
Implantation of venoarterial extracorporeal life support implant for refractory cardiogenic shock or cardiac arrest of any cause.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: Day 30
Death during hospital stay
Day 30
Overload detection, Echocardiographic parameters
Time Frame: Within 12 hours before the applied unloading technique

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%
Within 12 hours before the applied unloading technique
Unloading effectiveness, Echocardiographic parameters
Time Frame: 12 hours after the unloading technique implementation

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)
12 hours after the unloading technique implementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unloading Effectiveness, Qualitative echocardiographic parameters
Time Frame: 12 hours after the unloading technique implementation
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)
12 hours after the unloading technique implementation
Major adverse events
Time Frame: Day 30
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.
Day 30
Left Ventricular functional status
Time Frame: Day 30
Left ventricle Ejection fraction (%)
Day 30
LVAD Implementation
Time Frame: Day 30
LVAD implant
Day 30
Heart transplant
Time Frame: Day 30
Heart transplant
Day 30
Neurological status at discharge
Time Frame: Day 30
Cerebral Performance Category (CPC)
Day 30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic diameter (mm)
Time Frame: 12 hours after the unloading technique implementation
LV end-diastolic diameter (mm)
12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-diastolic volume (ml)
Time Frame: 12 hours after the unloading technique implementation
LV end-diastolic volume (ml)
12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic diameter (mm)
Time Frame: 12 hours after the unloading technique implementation
LV end-systolic diameter (mm)
12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LV end-systolic volume(ml)
Time Frame: 12 hours after the unloading technique implementation
LV end-systolic volume(ml)
12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, LA volume (ml)
Time Frame: 12 hours after the unloading technique implementation
LA volume (ml)
12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, E/E' septal and lateral (ratio, no unit of measurement )
Time Frame: 12 hours after the unloading technique implementation
E/E' septal and lateral (ratio, no unit of measurement )
12 hours after the unloading technique implementation
Unloading Effectiveness, Quantitative echocardiographic parameters, Systolic pulmonary artery pressure (mmHg)
Time Frame: 12 hours after the unloading technique implementation
Systolic pulmonary artery pressure (mmHg)
12 hours after the unloading technique implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

IRCCS Policlinico S. Donato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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