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临床试验/NCT01630577
NCT01630577已完成3 期

Early Change of Central Venous Pressure With Volume Challenge as Predictor of Fluid Responsiveness in Patients With Hemodynamic Instability

University of Monastir4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
70
试验地点
4
主要终点
fluid challange responsiveness

研究概览

简要总结

We conducted this study to assess the value of early change in central venous pressure (CVP) in predicting fluid responsiveness in mechanically ventilated patients.

详细描述

In patients with shock a primary goal of treatment is to restore and maintain organ perfusion, for which an adequate cardiac preload is required. Apart from the situations in which hypovolemia is evident and a favourable response to fluid administration will be seen, clinical and biological parameters often fail to predict hypovolemia. Inappropriate use of volume expansion carries out the risk of generating volume overload and pulmonary oedema. Consequently, reliable predictors of fluid responsiveness are needed especially in the early phase of cardiocirculatory deterioration. In the clinical setting, different static and dynamic indices have been shown to be useful indicators of cardiac preload. Central venous pressure (CVP) is widely used to measure right ventricular preload in patients requiring invasive hemodynamic monitoring. However, the use of the CVP is much criticized because CVP poorly predicts cardiac preload and volume status. However several decades ago, Weil and Henning proposed the fluid challenge technique, based on the 2-5 rule using CVP. There is a method for guiding volume repletion based on measurements of the patient's response to fluid load. This method has not been validated in the prediction of fluid responsiveness. We therefore conducted a prospective study that in all patients we measured CVP change and stroke volume variation (SVV) after administration of fluids. Patients were classified as fluid responders when their SVV is >10% after volume expansion and non-responders if SVV is ≤10%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • mechanically ventilated patients
  • acute circulatory failure defined by the need of vasopressive drugs (dopamine >5µg/kg/per minute or norepinephrine) with signs of tissue hypoperfusion (e.g., altered mental state, mottled skin, urine output below 0.5 ml per kilogram of body weight per hour during at least 2 h).
  • admission serum lactate level more than 2.5mmol/L

排除标准

  • severe hypoxemia defined as a ratio of arterial oxygen pressure to fraction of inspired oxygen [PaO2/FiO2] < 100 mmHg

结局指标

主要结局

fluid challange responsiveness

时间窗: within 20 minutes of fluid challenge

change of Stroke volume variation (SVV) by more than 10%

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nouira

professor

University of Monastir

研究点 (4)

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