GuMDel-ICU: The Gut Microbiota and Delirium in the ICU

Sponsor

Herlev Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03328377

Collaborator

University of Arkansas (Other)

Enrollment

6.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium of Mixed Origin Microbial Colonization	Diagnostic Test: Metagenomic analysis of gut microbiota

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Feb 28, 2018

Anticipated Study Completion Date :

May 31, 2018

Outcome Measures

Primary Outcome Measures

Gut Microbiota composition [May 2018]
Metagenomic analysis of Gut Microbiota / composition by different bacterial families

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Herlev Hospital
University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anne Sofie Andreasen, MD, ph.d, EDIC, MD,PhD, Herlev Hospital

ClinicalTrials.gov Identifier:

NCT03328377

Other Study ID Numbers:

GuMDel-ICU

First Posted:

Nov 1, 2017

Last Update Posted:

Nov 1, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Communicable Diseases

Infections

Delirium

Study Results

No Results Posted as of Nov 1, 2017