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临床试验/NCT05211765
NCT05211765招募中不适用

Association of Respiratory Variation of Superior Vena Cava in Transthoracic View and Fluid Responsiveness in Critically Ill Patients

University of Chile1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Fluid responsiveness

研究概览

简要总结

Fluid evaluation is relevant in critical care. Cardiac ultrasound is the first line of evaluation in hemodynamic characterization of patients in shock, to tailor therapy.

Fluid responsiveness predictors allow to better decide when to administer fluids, and transesophagic view of superior vena cava is an effective one. Recently a transthoracic view of the superior vena cava has been described.

The investigators aim to evaluate if the variations of superior vena cava can predict fluid responsiveness in critically il, ventilated patients.

Hypothesis: Respiratory variations of superior vena cava diameter, evaluated with transthoracic ultrasound, can predict fluid responsiveness

详细描述

Prospective evaluation of diameter variability of the superior vena cava by transthoracic echocardiography as fluid responsiveness predictor in critically ill patients:

Background Fluid administration is frequent in critically ill patients, particularly during reanimation and its empirical use is recommended as an initial step during this phase.

However, even though excess fluid administration is associated to negative outcomes fluid use is still being empirical and with scarce application of responsiveness predictors before its indication.

Different measurements or maneuvers exist, that allow clinicians to predict if a patient would present a positive fluid response, usually defined as cardiac output increasing 15% when infusing 500ml of crystalloids, and application of these predictive parameters could have clinical benefits on outcomes by avoiding inappropriate fluid administration.

As for the variables used, different types stand out. In general, flow or pressure variations originated in cardiothoracic interaction, auto-infusion and reduced fluid test evaluations such as the "mini" o "micro" fluid tests, in addition venous diameter variations in ultrasound evaluation with variable accuracy depending on the context. However, cardiothoracic interaction variables might have false positive results when right ventricular failure is present, given the cyclic increment on its afterload induced by positive pressure ventilation, reducing right ventricle stroke volume limiting its application in established or unknown and probable right heart failure if and advanced hemodynamic monitoring has not been performed to rule it out.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Patients >18 years,
  • Hospitalized in the Intensive Care Unit (ICU) with length of stay under 7 days
  • Under positive pressure ventilation with no inspiratory effort,
  • With hemodynamic instability (defined as abnormal peripheral perfusion or increased blood lactic or vasopressor infusion of norepinephrine >0.1 ug/kg/min to achieve adequate mean arterial pressure)

排除标准

  • Spontaneous ventilatory effort
  • Lack of venous access
  • Carrier of carbapenemase or clostridium difficile
  • Lack of adequate superior vena cava (SVC) window (not allowing M-mode during both respiratory phases)
  • Severe aortic regurgitation
  • Impossibility to measure LVOT-VTI
  • Extracorporeal membrane oxygenation.

结局指标

主要结局

Fluid responsiveness

时间窗: 1 minute

An increase of 10% or more in the left ventricle velocity time integral value (average of 3 in regular rhythms or 5 in irregular rhythms) measured with cardiac ultrasound in 5 chambers apical view after the infusion of 100ml bolus of intravenous crystalloid solution.

次要结局

未报告次要终点

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego Ugalde Castillo

Assistant professor

University of Chile

研究点 (1)

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