The Gut Microbiota and Delirium in the ICU

• Conditions: Delirium of Mixed Origin; Microbial Colonization

• Registration Number: NCT03328377
• Lead Sponsor: Herlev Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-28
• Study First Submitted QC: 2017-10-28
• Last Update Submitted: 2017-10-28
• Study Start: 2017-11-01
• Study First Posted: 2017-11-01
• Last Update Posted: 2017-11-01
• Primary Completion: 2018-02-28
• Study Completion: 2018-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut Microbiota composition	May 2018	Metagenomic analysis of Gut Microbiota / composition by different bacterial families