跳至主要内容
临床试验/NCT05625867
NCT05625867招募中不适用

Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2023年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
256
试验地点
1
主要终点
MOS SF-36 Quality of Life Scale Score

研究概览

简要总结

A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.

Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.

All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.

One month after discharge from the ICU, the patients will be randomly assigned to

  • either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit
  • or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Person who has given oral consent
  • Patient 18 years of age or older
  • Patient with at least one organ failure
  • Patient with a stay of 6 days or more

排除标准

  • Person who is not affiliated or not a beneficiary of a social security system
  • Patient at the end of his/her life
  • Patient who does not speak French
  • Minor (< 18 years old)
  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a legal protection measure
  • Pregnant, parturient or breastfeeding women
  • Patient incarcerated
  • Patient with a psychiatric history

结局指标

主要结局

MOS SF-36 Quality of Life Scale Score

时间窗: Between 4/5 and 9 months after discharge from intensive care

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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