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临床试验/NCT01980251
NCT01980251已完成不适用

Delirium, Electroencephalographic Alterations and Cortical Spreading Depression in Critical Illness

Glostrup University Hospital, Copenhagen1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU

研究概览

简要总结

Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up to 80 % of patients. It is associated with significantly increased morbidity and mortality during admission and post-discharge. The mechanism behind the condition is poorly understood but assumably multifactorial, and the purpose of this study is to investigate the pathophysiology further.

详细描述

The pathophysiology behind delirium in critical illness is not clarified but assumed to involve inflammation, changes in cerebral perfusion and neurotransmission, sleep deprivation and the use of i.e. sedatives.

Cortical spreading depression is a phenomenon occuring in critically ill patients with acute cerebral trauma and likely associated with significant secondary neuron damage.

The hypothesis is that

  1. Delirium in critically ill patients without acute cerebral damage is a clinical manifestation of cortical spreading depression and can be recorded in a noninvasive direct current-electroencephalography
  2. Electroencephalographic alterations or potentially specific signatures occur in delirium and thus, delirium can be predicted by recording continuous alternate current electroencephalography on admission in an ICU

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

  • expected admission in the ICU >24 hours

排除标准

  • Cerebral trauma <6 months
  • existing delirium
  • severe dementia

结局指标

主要结局

The occurence of electroencephalographic alterations and potential electroencephalographic signatures prior to and during delirium in the ICU

时间窗: 7 days

次要结局

  • The occurence of cortical spreading depression in noninvasive direct current-EEG in critically ill patients without acute cerebral trauma(Cortical spreading depression in the ICU)

研究者

发起方
Glostrup University Hospital, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rikke Malte Nielsen, M.D.

M.D.

Glostrup University Hospital, Copenhagen

研究点 (1)

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