Skip to content

The Gut Microbiota and Delirium in the ICU

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03328377
Acronym
GuMDel-ICU
Enrollment
50
Registered
2017-11-01
Start date
2017-11-01
Completion date
2018-05-31
Last updated
2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium of Mixed Origin, Microbial Colonization

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.

Interventions

DIAGNOSTIC_TESTMetagenomic analysis of gut microbiota

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

Sponsors

University of Arkansas
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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). \-

Design outcomes

Primary

MeasureTime frameDescription
Gut Microbiota compositionMay 2018Metagenomic analysis of Gut Microbiota / composition by different bacterial families

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026