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临床试验/NCT05961631
NCT05961631已完成不适用

The Use of Bio-Electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation in Critically Ill Patients Admitted to ICU: a Cohort Study

Indonesia University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年9月1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
200
试验地点
1
主要终点
Fluid accumulation (FA)

研究概览

简要总结

The purpose of this study is to assess fluid accumulation (FA) in the body using BIA (Bioelectrical Impedance Analysis) in critically ill patients treated in the ICU. This study is an observational cohort with an initial phase that analyzes prospective individual patient data

详细描述

This research will begin by identifying subjects through the collection of initial data. The identification of subjects will involve using BIA (Bioelectrical Impedance Analysis) equipment. Subsequently, the subjects will be divided into two groups based on the initial BIA test results of body fluid balance. The first group will comprise patients with a body fluid balance exceeding 500cc, while the second group will consist of patients with a body fluid balance of 500cc or less. Throughout the study, various BIA-derived parameters will be closely monitored for both groups, starting from the initial BIA test until the patients are discharged from the ICU or for a maximum of 7 days of ICU care from the time of the first test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • New patients admitted to Intensive Care Unit Cipto Mangunkusumo Hospital and Indonesia University University
  • Willing to be included in this research and signed the consent form

排除标准

  • Obesity(BMI>35kg/m²) OR underweight (BMI < 18,5 kg/m²)
  • Pregnant or Breastfeeding

结局指标

主要结局

Fluid accumulation (FA)

时间窗: 1 week

Each increase in volume excess is divided by the patient's initial body weight and expressed as a percentage. FA (fluid accumulation) is considered positive if the percentage value is greater than 5%. Conversely, FA is considered negative if the percentage value is less than 5%.

次要结局

  • volume excess (VE)(1 week)
  • total body weight (TBW)(1 week)
  • extracellular water (ECW)(1 week)
  • intracellular water (ICW)(1 week)

研究者

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

Dita Aditianingsih

Principal investigator, MD, PhD, Anesthesiologist Consultant

Indonesia University

研究点 (1)

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