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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04078503

Acronym

Delirium-fMRI

Enrollment

Registered

2019-09-06

Start date

2019-03-25

Completion date

2021-06-25

Last updated

2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Delirium

Keywords

neuroinflammation, fMRI, Functional MRI, ICU related delirium

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
fMRI alteration	6 months	Evaluation of brain functional alterations during delirium development (evaluated through resting state fMRI).
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

Countries

Italy

Outcome results