Clinical trial NCT04078503: Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Critical Illness
Keywords: neuroinflammation
fMRI
Functional MRI
ICU related delirium
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: University of Pisa
name: University of Turin, Italy
name: University of Milano Bicocca
name: Università degli Studi di Brescia
name: Mie University
name: Erasme University Hospital
name: Maastricht University
First posted: 2019-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll 30 critically ill patients in the study (case) matched to 30 controls (see sample size calculation).

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Serum Neuroinflammation biomarkers in patients developing delirium.
timeFrame: 15 days
Secondary outcomes:
measure: fMRI alteration
timeFrame: 6 months
measure: Correlation between biomarkers alterations and fMRI alterations
timeFrame: 15 days
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
Study officials:
References: