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临床试验/NCT01291368
NCT01291368已完成不适用

Does Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care?

University of Aarhus2 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2009年9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
248
试验地点
2
主要终点
Sedation level and Delirium

研究概览

简要总结

The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients influences the development of delirium during their ICU stay and if incidences of delirium have an impact on the development of Post-traumatic Stress-Disorder (PTSD).

Hypothesis 1:

Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of delirium than patients that are heavily sedated

Hypothesis 2:

Former delirious patients are more likely to develop PTSD

Hypothesis 3:

Delirium decreases health-related quality (HRQoL) of life after discharge

详细描述

Background:

It is known that ICU patients that experience delirium have longer hospital stay, higher mortality and morbidity. Other studies indicate that PTSD, dementia or depression may emerge after discharge from hospital.

Methods according to hypothesis 1:

During ICU stay: Measure sedation level & delirium. First follow-up 1-2 weeks after ICU: Memories

Analyses:

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

  • ICU-stay > 48 hours

排除标准

  • Severe brain trauma
  • Non-Danish-speaking
  • Age < 18 years
  • Death (only hypothesis 2 and 3 in the study)

结局指标

主要结局

Sedation level and Delirium

时间窗: At least twice a day while in the ICU

Sedation assessed with RASS and delirium assessed with the CAM-ICU by the nurses at the ICU

次要结局

  • Health-related quality of life(2 and 6 month after ICU-discharge)
  • Post Traumatic Stress Disorder(2 and 6 month after ICU-discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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