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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Unknown

Conditions: Delirium; Critical Illness

Study type: Observational

Funder types: Other

Identifiers

NCT04078503

NP3468

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

60 participants in 2 patient groups

Case

Description:

All patients aspected to stay in ICU for at least 3 days who will develop delirium

Control

Description:

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).