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临床试验/NCT01945541
NCT01945541已完成不适用

Body Composition Monitoring for Determination of the Fluid Status in Patients Undergoing General Anesthesia

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2013年8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
73
试验地点
2
主要终点
Postoperative overhydration in liter measured by Body Composition Monitor

研究概览

简要总结

The purpose of this study is to evaluate a recently developed device, which measures body composition (i.e. the water content of the body) in the perioperative setting. Specifically the investigators will test the hypothesis, that extracellular water content after surgery correlates to the amount of intraoperative infusion and positive fluid balance. Furthermore the investigators will test, if preoperative evaluation of body water helps to determine intraoperative fluid requirements and to guide fluid administration.

详细描述

Patients undergoing anesthesia and surgery receive intravenous fluids during the procedure. The amount of administered fluid depends on the type of surgery, cardiovascular stability and intraoperative losses like hemorrhage. Fluid overload as well as hypohydration might be detrimental and might adversely effect outcome after surgery. Specifically overhydration results in significant weight gain, tissue edema and increased morbidity. Technically assisted assessment of volume status before surgery may be useful to direct intraoperative fluid administration and to prevent postoperative volume overload. As a prerequisite the investigators will test a recently developed whole-body bioimpedance spectroscopy device to determine the pre-to postoperative fluid distribution. This body composition monitor (BCM, Fresenius Medical Care, Germany) separates between extracellular and intracellular fluid volume non-invasively by applying a frequency sweep from 3-1000 kilohertz through the entire patient via electrodes placed on the wrist and ankle.

The investigators will test the hypothesis that

  1. the amount of administered fluid correlates with the amount of overhydration measured postoperatively.
  2. that preoperative BCM measurements and thus information about the preoperative hydration state might help to guide fluidmanagement and to reduce the amount of over/ hypohydration postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-80 Years

排除标准

  • liver, heart, kidney failure, patients with pacemaker

结局指标

主要结局

Postoperative overhydration in liter measured by Body Composition Monitor

时间窗: Measurements will be performed immediatley before and after surgery. The expected time frame will thus be 2-4 hours.

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

Barbara Kabon

PD. MD.

Medical University of Vienna

研究点 (2)

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