Delirium of Mixed OriginGuMDel-ICUNCT03328377
The Gut Microbiota and Delirium in the ICU
An observational study of Delirium of Mixed Origin and Microbial Colonization, run by Herlev Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium of Mixed Origin, Microbial Colonization
- What is being tested?
- Metagenomic analysis of gut microbiota
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 40 ICU patients and 10 healthy volunteers as controls
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).
-
About this study
Official title: The Association Between the Gut Microbiota Composition and Development of Delirium in ICU Patients
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.
Read the 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.
- Conditions
- Delirium of Mixed Origin, Microbial Colonization
- Being tested
- Metagenomic analysis of gut microbiota
- Medical subject headings
- Delirium, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metagenomic analysis of gut microbiotaDiagnostic test
All patients have rectal swaps/fecal samples subjected to metagenomic analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiota composition
Metagenomic analysis of Gut Microbiota / composition by different bacterial families
Measured: May 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Nov 2017 (estimated)
- Primary completion28 Feb 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium of Mixed OriginStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Anne Sofie Andreasen, MD, ph.d, EDIC, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328377
- Sponsor's protocol ID
- GuMDel-ICU
- Acronym
- GuMDel-ICU
- Status last verified
- Oct 2017
- First submitted
- 28 Oct 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between the Gut Microbiota Composition and Development of Delirium in ICU Patients
- ClinicalTrials.gov ID
- NCT03328377
- Acronym / sponsor ID
- GuMDel-ICU / GuMDel-ICU
- Conditions
- Delirium of Mixed Origin, Microbial Colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 40 ICU patients and 10 healthy volunteers as controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metagenomic analysis of gut microbiotaAll patients have rectal swaps/fecal samples subjected to metagenomic analysis | Diagnostic test | – |
Primary outcome
Gut Microbiota composition
Time frame: May 2018
Metagenomic analysis of Gut Microbiota / composition by different bacterial families
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium of Mixed Origin and Microbial Colonization, run by Herlev Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota composition (time frame: May 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.