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临床试验/NCT01827007
NCT01827007已完成不适用

Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock

Helsinki University Central Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.

研究概览

简要总结

The aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test). The chances are compared to increase of CI after volume expansion (gold standard). In clinical practise, it would be especially relevant if PEEP-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. However, as ECHO-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic measurements is essential in the study design.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent by patient or relative
  • Time in ICU < 48 hours
  • Septic shock
  • Pulmonary artery catheter and radial arterial catheter
  • Age 18 - 75 years
  • Sinus rhythm
  • Need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study
  • Mechanical ventilation with sedation
  • Pwcp <18 mmHg

排除标准

  • Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication )
  • Contraindication to fluid challenge
  • Contraindication to TEE
  • Previous heart failure, heart valve stenosis of insufficiency

结局指标

主要结局

Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.

时间窗: Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes

Measurement of hemodynamic variables using a pulmonary catheter and transesophageal echocardiography at baseline PEEP 10, during elevation of PEEP and after volume challenge at PEEP 10 cmH2O

次要结局

  • Pulmonary function and oxygenation(0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O)

研究者

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

Erika Wilkman

M.D

Helsinki University Central Hospital

研究点 (2)

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