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| Name | Class |
|---|---|
| University of Pisa | OTHER |
| University of Turin, Italy | OTHER |
| University of Milano Bicocca | OTHER |
| Università degli Studi di Brescia |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Neuroinflammation biomarkers in patients developing delirium. | Comparison of neuroinflammation biomarkers in patients developing delirium vs patients who do not develop delirium. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI alteration | Evaluation of brain functional alterations during delirium development (evaluated through resting state fMRI). | 6 months |
| Correlation between biomarkers alterations and fMRI alterations |
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Inclusion Criteria:
Exclusion Criteria:
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We will enroll 30 critically ill patients in the study (case) matched to 30 controls (see sample size calculation).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
The database is in RedCap. We could share all data
Already available
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| OTHER |
| Mie University | OTHER |
| Erasme University Hospital | OTHER |
| Maastricht University | OTHER |
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serum
Evaluation of the correlation between serum neuroinflammation biomarkers alteration during delirium development and the alterations noted in during resting state fMRI
| 15 days |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D016638 | Critical Illness |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D007249 | Inflammation |
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