A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- In-hospital mortality
研究概览
简要总结
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;
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing VA ECLS will be enrolled.
排除标准
- •Patients without VA ECMO will not be considered
结局指标
主要结局
In-hospital mortality
时间窗: Day 30
Death during hospital stay
Overload detection, Echocardiographic parameters
时间窗: 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
时间窗: 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)
次要结局
- Unloading Effectiveness, Qualitative echocardiographic parameters(12 hours after the unloading technique implementation)
- Major adverse events(Day 30)
- Left Ventricular functional status(Day 30)
- LVAD Implementation(Day 30)
- Heart transplant(Day 30)
- Neurological status at discharge(Day 30)
