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Delirium-fMRI: Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study

Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
Overall Status
Unknown status
CT.gov ID
NCT04078503
Collaborator
University of Pisa, Italy (Other), University of Turin, Italy (Other), University of Milano Bicocca (Other), Università degli Studi di Brescia (Other), Mie University (Other), Erasme University Hospital (Other), Maastricht University (Other)
60
Enrollment
1
Location
27
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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 structural and functional alterations (using brain fMRI).

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Mar 25, 2019
    Anticipated Primary Completion Date :
    Mar 25, 2021
    Anticipated Study Completion Date :
    Jun 25, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Serum Neuroinflammation biomarkers in patients developing delirium. [15 days]

      Comparison of neuroinflammation biomarkers in patients developing delirium vs patients who do not develop delirium.

    Secondary Outcome Measures

    1. fMRI alteration [6 months]

      Evaluation of brain functional alterations during delirium development (evaluated through resting state fMRI).

    2. Correlation between biomarkers alterations and fMRI alterations [15 days]

      Evaluation of the correlation between serum neuroinflammation biomarkers alteration during delirium development and the alterations noted in during resting state fMRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age>18

    • All patients admitted that would be expected to stay in ICU for at least 3 days

    Exclusion Criteria:

    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spedali Civili di Brescia Brescia Italy 25123

    Sponsors and Collaborators

    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
    • University of Pisa, Italy
    • University of Turin, Italy
    • University of Milano Bicocca
    • Università degli Studi di Brescia
    • Mie University
    • Erasme University Hospital
    • Maastricht University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Piva Simone, Assistant Professor, Università degli Studi di Brescia
    ClinicalTrials.gov Identifier:
    NCT04078503
    Other Study ID Numbers:
    • NP3468
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Piva Simone, Assistant Professor, Università degli Studi di Brescia
    neuroinflammation
    fMRI
    Functional MRI
    ICU related delirium
    Additional relevant MeSH terms:
    Delirium
    Critical Illness

    Study Results

    No Results Posted as of Sep 6, 2019