NCT03328377

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

October 28, 2017

Last Update Submit

October 28, 2017

Conditions

Delirium of Mixed OriginMicrobial Colonization

Outcome Measures

Primary Outcomes (1)

  • Gut Microbiota composition

    Metagenomic analysis of Gut Microbiota / composition by different bacterial families

    May 2018

Interventions

Metagenomic analysis of gut microbiotaDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 40 ICU patients and 10 healthy volunteers as controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Fecalsamples/Rectal swaps

MeSH Terms

Conditions

DeliriumCommunicable Diseases

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersInfectionsDisease AttributesPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

October 28, 2017

First Posted

November 1, 2017

Study Start

November 1, 2017

Primary Completion

February 28, 2018

Study Completion

May 31, 2018

Last Updated

November 1, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share