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临床试验/NCT03326635
NCT03326635已完成不适用

Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.

Hospices Civils de Lyon37 个研究点 分布在 2 个国家目标入组 527 人开始时间: 2018年4月8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
527
试验地点
37
主要终点
Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)

研究概览

简要总结

Study design. The study FRAGIREA is a multicentric prevalence study on the frequency of frailty among elderly patients and the quality of management. The voluntary ICUs will have to include all patients ≥ 70 years on a limited period (1 month) or until the number of 15 inclusions is reached. The frailty is going to be evaluated by a frailty score adapted to the ICU, based on informations given by the patient's family.

It is a descriptive non-interventional study, aiming at the description of frequency of frailty and management of the patient in order to set-up a prospective future study on the potential role of early rehabilitation of ageing patients in ICUs.

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 70 year-old
  • Prevision of a length of stay > 24 hrs.
  • Patient or relative who received information about the study and did not oppose it

排除标准

  • Life expectancy < 24 hrs
  • Patients unable to communicate and no next of kin available.
  • adults, non-emancipated minors, persons unable to receive information,
  • persons placed under the safeguard of justice,
  • subject participating in another search including an exclusion period still in progress at pre-inclusion

结局指标

主要结局

Frailty in elderly (≥70 years old) patients in intensive care unit (ICU)

时间窗: One month or 15 patients ≥ 70 years old

We assessed the 5 components of Fried's frailty index, resulting from cumulative decline across multiple physiological systems and contain five criteria (shrinking, weakness, slowness, low-level physical activity, and self-reported exhaustion). All five components were considered from the previously reported definition and adapted to the ICU environment. The patients were considered to be frail if they had three or more frailty components among the five criteria.

次要结局

  • Organ failures(About 8 days)
  • Nutritional support(About 8 days)
  • Rehabilitation(About 8 days)
  • Mortality(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (37)

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