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临床试验/NCT04434079
NCT04434079已完成不适用

Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2018年6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
98
试验地点
1
主要终点
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight

研究概览

简要总结

Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

详细描述

Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in intensive care unit (ICU). In view of the potential for errors in the calculation of FB totals and the problem of accounting for insensible fluid losses, measurement of body weight (BW) changes is an alternative non-invasive method commonly used for estimating body fluid status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain or loss in body fluid volume. However, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in ICU possibly due to muscle and fat loss as well as bone demineralization. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Individuals aged >18 years-old admitted to ICU;
  • Expected length of ICU stay superior to 24 hours.

排除标准

  • Individuals receiving oral diet;
  • Actual body weight superior to 227kgs or 501lb.

结局指标

主要结局

Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight

时间窗: At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.

Correlation between daily fluid balance and weight change (Bland-Altman agreement test)

次要结局

  • Discriminative power of fluid balance in predicting ICU mortality(Through study completion, up to 6 months)
  • Correlation between cumulative fluid balance and total weight change(Last day of each patient's ICU hospitalization, up to 6 months)
  • Discriminative power of body weight changes in predicting ICU mortality(Through study completion, up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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