The Gut Microbiota and Delirium in the ICU

NCT ID: NCT03328377

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Delirium of Mixed Origin Microbial Colonization

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Metagenomic analysis of gut microbiota

All patients have rectal swaps/fecal samples subjected to metagenomic analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Sofie Andreasen, MD, ph.d, EDIC

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GuMDel-ICU

Identifier Type: -

Identifier Source: org_study_id