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临床试验/NCT04984603
NCT04984603Unknown不适用

Evaluation of the Ability of PAssive Leg RAising Combined to Transthoracic Echography, Pulse Pressure and EtCO2 Monitoring to Predict an Increase of Native Cardiac Output After Fluid Administration in Patients Assisted by VA-ECMO

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Correlation between VTI changes induced by PLR and VTI changes induced by fluid challenge

研究概览

简要总结

Peripheral Veno-Arterial Extra Corporeal Membrane Oxygenation (VA ECMO) is a temporary assistance that provides a mechanical circulatory support in patients victim of cardiogenic shock (CS) or refractory cardiac arrest.

During VA-ECMO support, hypotension may frequently occur due to deteriorated cardiac function, vasoplegia, or hypovolemia. Volume expansion is a common means to correct hypotension and improve systemic perfusion, but inappropriate fluid therapy is associated with adverse outcomes. As other intensive care unit (ICU) patients, VA-ECMO assisted patients have been shown to have higher mortality in case of large early fluid administration. Prediction of fluid responsiveness could achieve a lower fluid balance and improve outcomes of patients treated with VA-ECMO.

Several dynamic hemodynamic parameters based on cardio-pulmonary interactions (stroke volume, pulse pressure or inferior vena cava variations induced by invasive ventilation cycles) have been described and validated for predicting fluid responsiveness in critically ill patients. Unfortunately, the VA-ECMO conditions (native cardiac circulation by-pass, low pulsatility, presence of drainage canulation in the inferior vena cava, the use of low tidal volume) make this parameters less reliable.

Simulation of a fluid loading by shifting blood from the lower limbs and splanchnic compartment thanks to a revisable maneuver is another feasible approach to assess fluid responsiveness. Whereas the use of different maneuvers have been validated in the classical ICU population, very few data exist in the ECMO population and their application is questioning because blood transfer may be modified by the preload dependence of the ECMO. Recently, Luo et al showed that the variation of aortic Velocity Time Integral (VTI) measured using echocardiography induced by a Trendelenburg maneuver was predictive of fluid responsiveness during VA-ECMO support. However, their study excluded patients with low cardiac ejection (pulse pressure < 15 mmHg) so that their data may not be extrapolated to the acute phase of heart failure requiring full mechanical support.

Moreover, aortic VTI measurement suffers from low reproducibility in case of low native cardiac output (NCO) and arrythmia; and can be time-consuming. The investigators previously demonstrated in an observational prospective study that End-tidal CO2 (EtCO2) and Pulse Pressure (PP) were strongly correlated to NCO during VA-ECMO when NCO < 2l/min.

The investigators aim to study the variations of aortic VTI, EtCO2 and PP induced by Passive Leg Rising (PLR) and their ability to predict fluid responsiveness in patients under VA-ECMO.

详细描述

Settings :

This prospective non interventional study is conducted since february 2020 in the investigators' ICU and has been approved by their hospital's institutional review board. Informed consent is obtained from all patients or their surrogates.

Patients :

All patients who receive VA-ECMO support and mechanical ventilation for refractory cardiogenic shock or cardiac arrest of any etiology (acute myocardial infarction, end-stage dilated cardiomyopathy, heart surgery, fulminant myocarditis...) are screened.

Patients conditioning :

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation between VTI changes induced by PLR and VTI changes induced by fluid challenge

时间窗: During VA-ECMO support (<28 days)

VTI variations induced by PLR vs VTI variations induced by fluid challenge

次要结局

  • Correlation between PP changes induced by PLR and PP changes induced by fluid challenge(During VA-ECMO support (<28 days))
  • Correlation between EtCO2 changes induced by PLR and EtCO2 changes induced by fluid challenge(During VA-ECMO support (<28 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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