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临床试验/NCT04665349
NCT04665349已完成不适用

Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments

Medical University of Gdansk2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
Amount of total body water

研究概览

简要总结

Preoperative fasting is defined as refraining from food for at least 6 hours and clear fluids for at least 2 hours prior to anaesthesia. On the one hand, it is a procedure that reduces the risk of aspiration of food content and the occurrence of Mendelson's syndrome, and on the other hand, it was considered to be the cause of disturbances in water management in patients undergoing general anaesthesia. However, reports from recent years have found that moderate preoperative fasting does not influence the risk of hypovolemia in anesthetized patients. It is also known that in fasting people the total body water is reduced. Thus, it can be assumed that there are mechanisms causing the movement of extravascular water into the lumen of blood vessels. For several years, the Body Composition Monitor (BCM) device for non-invasive measurement of the volume of individual water compartments of the human body has been available on the market. It allows to determine the volume of total body water, intracellular body water and extracellular body water. It is mainly used during dialysis, but it can also be used in other circumstances that require the determination of the body's hydration status. The principle of this method is based on non-invasive bioimpedance measurement with the use of 4 electrodes placed on two extremities.

The aim of the study is to determine whether there is a fluid shift between the intracellular and extracellular compartments in people undergoing preoperative fasting. Examination of this issue would allow for the development of hypothesis regarding the optimal perioperative fluid therapy. If there was a shift of fluid from the intracellular space, it seems more rational to supplement fluid deficiencies resulting from starvation with a 5% glucose solution. If, on the other hand, no fluid shift from the intracellular space was detected, which would suggest shifts within the extracellular space, it would be advisable to hydrate the patient with crystalloid solutions.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) general condition assessment 1 or 2

排除标准

  • Chronic kidney disease
  • Circulatory failure
  • Phenylketonuria
  • History of hypoglycaemic episodes or any carbohydrate metabolism disorders.

结局指标

主要结局

Amount of total body water

时间窗: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Measurements will be done with Fresenius Body Composition Monitor

Extracellular to intracellular water ratio

时间窗: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Measurements will be done with Fresenius Body Composition Monitor

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

Radosław Owczuk

Clinical Professor, Head of Department of Anaesthesiology and Intensive Care

Medical University of Gdansk

研究点 (2)

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