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

NCT04078503 | Unknown DMC

• 1 other identifier: NP3468
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Delirium; Critical Illness

Keywords

neuroinflammation; fMRI; Functional MRI; ICU related delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• fMRI alteration

  6 months

• Correlation between biomarkers alterations and fMRI alterations

  15 days

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age\>18
• All patients admitted that would be expected to stay in ICU for at least 3 days

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• University of Pisa: collaborator
• University of Turin, Italy: collaborator
• University of Milano Bicocca: collaborator
• Università degli Studi di Brescia: collaborator
• Mie University: collaborator
• Erasme University Hospital: collaborator
• Maastricht University: collaborator

Study Sites (1)

Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Delirium; Critical Illness; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Inflammation

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: September 6, 2019
• Study Start: March 25, 2019
• Primary Completion: March 25, 2021
• Study Completion: June 25, 2021
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Already available

Locations

IT (1)