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NCT03328377 Clinical Trial

The Gut Microbiota and Delirium in the ICU

Microbial Colonization Clinical Trial

— GuMDel-ICU  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03328377
Other study ID # GuMDel-ICU
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 28, 2017
Last updated October 28, 2017
Start date November 1, 2017
Est. completion date May 31, 2018

Study information
Verified date October 2017
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date May 31, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Metagenomic analysis of gut microbiota
All patients have rectal swaps/fecal samples subjected to metagenomic analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Herlev Hospital University of Arkansas

Outcome
Type Measure Description Time frame Safety issue
Primary Gut Microbiota composition Metagenomic analysis of Gut Microbiota / composition by different bacterial families May 2018
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