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

Critical Illness Clinical Trial

— Delirium-fMRI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04078503
• Other study ID #: NP3468
• Status: Recruiting
• Start date: March 25, 2019
• Est. completion date: June 25, 2021

Study information

• Verified date: September 2019
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Locations

Country	Name	City	State
Italy	Spedali Civili di Brescia	Brescia

Sponsors (8)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia	Erasme University Hospital, Maastricht University, Mie University, Università degli Studi di Brescia, University of Milano Bicocca, University of Pisa, Italy, University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Neuroinflammation biomarkers in patients developing delirium.	Comparison of neuroinflammation biomarkers in patients developing delirium vs patients who do not develop delirium.	15 days
Secondary	fMRI alteration	Evaluation of brain functional alterations during delirium development (evaluated through resting state fMRI).	6 months
Secondary	Correlation between biomarkers alterations and fMRI alterations	Evaluation of the correlation between serum neuroinflammation biomarkers alteration during delirium development and the alterations noted in during resting state fMRI	15 days