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临床试验/NCT03044405
NCT03044405已完成不适用

Focused Assessed Echocardiography to Predict Fluid Responsiveness for Non-cardiac Hypotensive Spontaneously Breathing Patients After Major Abdominal Surgery

Lithuanian University of Health Sciences0 个研究点目标入组 40 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
All hypotensive patients are divided into responders and non-responders according to increase of left ventricle outflow tract velocity time integral (LVOT VTI) after fluid challenge.

研究概览

简要总结

The aims of the study are:

  1. To evaluate the feasibility of echocardiography monitoring in postoperative unit;
  2. To assess diagnostic value of different focussed echocardiography parameters to define fluid responsiveness for non-cardiac hypotensive spontaneously breathing patients after major abdominal surgery.

详细描述

As there are different strategies of perioperative fluid management discussion which is the choice liberal or restrictive one occurs? Individualized infusion therapy should be the goal. The investigators hypothesize extended hemodynamic monitoring based on focused transthoracic echocardiography enable to differentiate the cause of hypotension more carefully and fluid overload will be avoided after major abdominal surgery.

The goals of the study are:

  • To conduct one group of hypotensive patients after major abdominal surgery. To divide this group into responders and nonresponders after fluid challenge.
  • To evaluate the feasibility of echocardiography monitoring in postoperative unit (having in mind such restrains as supine position, postoperative pain, bandages etc.)
  • To compare the evaluation of fluid responsiveness by clinical signs and focused assessed echocardiography data.
  • To identify the best focused echocardiography parameters for prognosis of fluid responsiveness.
  • To determine if extended hemodynamic monitoring changes postoperative fluid management.

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
是

入选标准

  • •Age more than 18 years old.
  • •Patients who sign an agreement form to participate in the study.
  • •Patients undergoing major abdominal surgery.
  • •Hypotension

排除标准

  • •Younger than 18 years old.
  • •Known pregnancy.
  • •Unconscious patients or those who do not agree to participate in the study.
  • •Urgent surgery.
  • •Normal arterial blood pressure.

研究组 & 干预措施

Responders and non-responders

Other

Fluid challenge of 500 ml of crystalloids over 15 minutes is given. Positive fluid responsiveness is defined by an increase in stroke volume (SV) of at least 15% assessed by focused transthoracic echocardiography.

干预措施: Fluid challenge (Diagnostic Test)

Responders and non-responders

Other

Fluid challenge of 500 ml of crystalloids over 15 minutes is given. Positive fluid responsiveness is defined by an increase in stroke volume (SV) of at least 15% assessed by focused transthoracic echocardiography.

干预措施: Focused transthoracic echocardiography (Diagnostic Test)

结局指标

主要结局

All hypotensive patients are divided into responders and non-responders according to increase of left ventricle outflow tract velocity time integral (LVOT VTI) after fluid challenge.

时间窗: the first hour after the surgery

Fluid challenge - fluid bolus of 500 ml of crystalloids which is given over 15 minutes. Positive fluid responsiveness is defined by an increase in stroke volume of at least 15%. Measurements are taken before and immediately after fluid challenge.

次要结局

  • The frequency of fluid responsiveness defined by clinical signs and focused transthoracic echocardiography data after fluid challenge is compared.(the first hour after the surgery)
  • Mitral E wave velocity (cm/s) is compared between responders and non-responders.(the first hour after the surgery)
  • E/A ratio is compared between responders and non-responders.(the first hour after the surgery)
  • Variability of LVOT VTI (%) during breathing cycles is compared between responders and non-responders.(the first hour after the surgery)
  • Cardiac index (L/min/m2) is compared between responders and non-responders.(the first hour after the surgery)
  • Variability of inferior vena cava (%) is compared between responders and non-responders.(the first hour after the surgery)
  • The planed infusion therapy before and after evaluation by focused transthoracic echocardiography is compared in responders and non-responders.(the first 24 hours after the surgery)

研究者

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

Asta Maculiene

Principal Investigator

Lithuanian University of Health Sciences

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