DeliriumDelirium-fMRINCT04078503
Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study
An observational study of Delirium and Critical Illness, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
With the present study, the authors aim to improve the knowledge of the pathophysiology of ICU-related delirium. In particular, the authors would like to clarify the possible correlation between neuroinflammation, evaluated longitudinally by serum dosage of 20 different neuroinflammation biomarkers, and brain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Critical Illness
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2019to 25 Jun 2021
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll 30 critically ill patients in the study (case) matched to 30 controls (see sample size calculation).
Who may be able to join
- Age>18
- All patients admitted that would be expected to stay in ICU for at least 3 days
Who cannot join
- Acute neurological condition
- Chronic neurological condition (i.e., seizures, stroke, muscular illness).
- Hematological malignancy or immunological disease.
- Blood transfusion in the last 2 weeks
- Ongoing sedation
- Any condition which contraindicates MRI execution (presence of non-compatible devices or hemodynamic or respiratory instability).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Spedali Civili di Brescia
Brescia, 25123
Simone Piva, +393332564230 ext. +393332564230, simone.piva@unibs.it
Fabio Turla, +393332564230, fabioturla2@gmail.com
About this study
With the present study, the authors aim to improve the knowledge of the pathophysiology of ICU-related delirium. In particular, the authors would like to clarify the possible correlation between neuroinflammation, evaluated longitudinally by serum dosage of 20 different neuroinflammation biomarkers, and brain structural and functional alterations (using brain fMRI).
Read the detailed description
Pathophysiology of delirium is poorly understood; neuroinflammation and brain network disruption are claimed as possible causes of delirium.
The authors want to clarify the role of the alterations of different cellular components of neuroinflammation (neurons, glial cells, and endothelium) in delirium development. Moreover, the authors want to understand whether the neuroinflammation process could cause permanent structural and functional brain damage.
In a nested cross-sectional longitudinal case-control observational study in ICU admitted patients.
The objectives of the studies are as follow: 1) Neuroinflammation biomarkers evaluation in non-neurological ICU patients who develop delirium during ICU-stay (case) compared to matched non-delirious ICU patients (control), and 2) their correlation with brain structural and functional alterations evaluated with a resting-state fMRI protocol and PET.
- Conditions
- Delirium, Critical Illness
- Keywords
- neuroinflammation, fMRI, Functional MRI, ICU related delirium
- Medical subject headings
- Delirium, Critical Illness, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | All patients aspected to stay in ICU for at least 3 days who will develop delirium | |
| Control | All patients aspected to stay in ICU for at least 3 days who will not develop delirium (1:1 matched with the controls with a propensity score method). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Neuroinflammation biomarkers in patients developing delirium.
Comparison of neuroinflammation biomarkers in patients developing delirium vs patients who do not develop delirium.
Measured: 15 days
Secondary outcomes (2)
fMRI alteration
Evaluation of brain functional alterations during delirium development (evaluated through resting state fMRI).
Measured: 6 months
Correlation between biomarkers alterations and fMRI alterations
Evaluation of the correlation between serum neuroinflammation biomarkers alteration during delirium development and the alterations noted in during resting state fMRI
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start25 Mar 2019
- Primary completion25 Mar 2021 (estimated)
- Study completion25 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa, University of Turin, Italy, University of Milano Bicocca, Università degli Studi di Brescia, Mie University, Erasme University Hospital, Maastricht University
- Responsible party
- Principal investigator, Piva Simone, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078503
- Sponsor's protocol ID
- NP3468
- Acronym
- Delirium-fMRI
- Status last verified
- Sep 2019
- First submitted
- 30 Mar 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The database is in RedCap. We could share all data
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study
- ClinicalTrials.gov ID
- NCT04078503
- Acronym / sponsor ID
- Delirium-fMRI / NP3468
- Conditions
- Delirium, Critical Illness
- Keywords
- neuroinflammation, fMRI, Functional MRI, ICU related delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- University of Pisa, University of Turin, Italy, University of Milano Bicocca, Università degli Studi di Brescia, Mie University, Erasme University Hospital, Maastricht University
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 Mar 2021 (estimated)
- Study completion
- 25 Jun 2021 (estimated)
- First posted
- 6 Sep 2019 (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.
With the present study, the authors aim to improve the knowledge of the pathophysiology of ICU-related delirium. In particular, the authors would like to clarify the possible correlation between neuroinflammation, evaluated longitudinally by serum dosage of 20 different neuroinflammation biomarkers, and brain structural and functional alterations (using brain fMRI).
Detailed description
Pathophysiology of delirium is poorly understood; neuroinflammation and brain network disruption are claimed as possible causes of delirium.
The authors want to clarify the role of the alterations of different cellular components of neuroinflammation (neurons, glial cells, and endothelium) in delirium development. Moreover, the authors want to understand whether the neuroinflammation process could cause permanent structural and functional brain damage.
In a nested cross-sectional longitudinal case-control observational study in ICU admitted patients.
The objectives of the studies are as follow: 1) Neuroinflammation biomarkers evaluation in non-neurological ICU patients who develop delirium during ICU-stay (case) compared to matched non-delirious ICU patients (control), and 2) their correlation with brain structural and functional alterations evaluated with a resting-state fMRI protocol and PET.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –All patients aspected to stay in ICU for at least 3 days who will develop delirium |
| Control | – | –All patients aspected to stay in ICU for at least 3 days who will not develop delirium (1:1 matched with the controls with a propensity score method). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll 30 critically ill patients in the study (case) matched to 30 controls (see sample size calculation).
Key inclusion criteria (2 listed)
- Age>18
- All patients admitted that would be expected to stay in ICU for at least 3 days
Key exclusion criteria (6 listed)
- Acute neurological condition
- Chronic neurological condition (i.e., seizures, stroke, muscular illness).
- Hematological malignancy or immunological disease.
- Blood transfusion in the last 2 weeks
- Ongoing sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Neuroinflammation biomarkers in patients developing delirium.
Time frame: 15 days
Comparison of neuroinflammation biomarkers in patients developing delirium vs patients who do not develop delirium.
2 secondary outcomes
fMRI alteration
Time frame: 6 months
Correlation between biomarkers alterations and fMRI alterations
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Yes. The database is in RedCap. We could share all data
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Critical Illness, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Neuroinflammation biomarkers in patients developing delirium. (time frame: 15 days). 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 6 Sep 2019.