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临床试验/NCT01367093
NCT01367093已完成不适用

French and EuRopean Outcome Registry in Intensive Care Unit

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 2,137 人开始时间: 2011年7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
2,137
试验地点
2
主要终点
All cause mortality at one year after ICU discharge

研究概览

简要总结

The purpose of this study is to identify within a cohort of ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.

详细描述

FROG-ICU is an epidemiological, observational, prospective, multi centric, cohort study designed for description, prognostic and evaluation. This trial includes as a first step a complete registry of patients admitted to the ICU and as a second step, the outcome of the patients at 1 year after they have been discharged alive from ICU.

Plasma and urine samples will be with drawn biomarkers measurements at admission and ICU discharge. It is a multicentric study involving 1 center in Belgium et 24 centers in France.

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

  • 未提供

排除标准

  • age < 18 years
  • pregnancy women
  • Breast-feeding women
  • Not affiliated with social security
  • Dying man
  • End of life patient
  • Traumatic Brain Injury (IGCS < 8)
  • vegetative coma
  • Transplanted for less than year
  • no french speaking patient
  • out of france resident
  • end of life decision during the following

结局指标

主要结局

All cause mortality at one year after ICU discharge

时间窗: one year

次要结局

  • To identify key determinants of cardiovascular morbidity and mortality in the year following a stay in ICU(one year)
  • To investigate the performance of plasma biomarkers usually measured in ICU, to assess the risk of death during the stay in ICU and one year after the discharge.(one year)
  • To set up a biological collection of plasma and urine, in order to measure new plasma biomarkers in the assessment of prognosis in the year following a stay in ICU.(one year)
  • To assess quality of life in the year following a stay in ICU(one year)
  • to evaluate social conditions(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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