ECMO LEft Ventricle UNloading Strategy

Recruiting

• Conditions: Shock, Cardiogenic; Cardiac Arrest; Extracorporeal Membrane Oxygenation Complication

• Registration Number: NCT06766006
• Lead Sponsor: Maastricht University Medical Center

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.

Study Timeline

• Study First Submitted: 2023-12-14
• Study Start: 2024-04-01
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients undergoing VA ECLS will be enrolled.

Exclusion Criteria

• Patients without VA ECMO will not be considered

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	Day 30	Death during hospital stay
Overload detection, Echocardiographic parameters	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%
Unloading effectiveness, Echocardiographic parameters	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)

Secondary Outcome Measures

Name	Time	Method
Unloading Effectiveness, Qualitative echocardiographic parameters	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)
Major adverse events	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.
Left Ventricular functional status	Day 30	Left ventricle Ejection fraction (%)
LVAD Implementation	Day 30	LVAD implant
Heart transplant	Day 30	Heart transplant
Neurological status at discharge	Day 30	Cerebral Performance Category (CPC)

Trial Locations

Locations (1)

Maastricht UMC; 🇳🇱 Maastricht, Netherlands