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临床试验/NCT03328377
NCT03328377Unknown不适用

The Association Between the Gut Microbiota Composition and Development of Delirium in ICU Patients

Herlev Hospital0 个研究点目标入组 50 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Gut Microbiota composition

研究概览

简要总结

To investigate whether the composition of the gut microbiota is different in patients that develop delirium during critical illness as compared to patients who do not.

详细描述

We plan to include an equal number of patients admitted to the ICU, that either do or don't develop delirium during their course of critical illness. Samples of feces/rectal swaps will be taken at admission and again either when the patients become CAM-ICU positive, alternatively after 5 days admssion/at discharge in patients that remain CAM-ICU negative.

Samples are then sent to analyses for purification of bacterial DNA and metagenomic analysis.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Admission to the ICU, Disability to make informed consent due to critical illness -

排除标准

  • Dementia. Delirium diagnosed prior to the ICU admission on the non-ICU floors. Coma. Indication for deep sedation (-4/-5).

结局指标

主要结局

Gut Microbiota composition

时间窗: May 2018

Metagenomic analysis of Gut Microbiota / composition by different bacterial families

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Sofie Andreasen, MD, ph.d, EDIC

MD,PhD

Herlev Hospital

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