Functional Magnetic Resonance Imaging (fMRI) of Brain in ICU Survivors With Cognitive Impairment

NCT ID: NCT03946839

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2024-01-20

Brief Summary

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Long-term cognitive dysfunction greatly influences patient's quality of life after critical illness. However,its neurophysiological basis remains unknown.This is a 3 year fMRI study conducted at the Jiangyin people's Hospital. This study utilize resting-state functional magnetic resonance imaging(fMRI) to investigate the regional alterations in survivors with cognitive impairment.Further, the investigators hypothesize that these regional changes in fMRI activity are predictive of cognitive impairment.

Detailed Description

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Critically ill patients who had hospitalized in ICU at least 2 days and who consented to participate will take the examination of brain fMRI,blood inflammatory markers and cognitive assessment after ICU discharge. Individuals of healthy control group are recruited from the community will be made to match them on age,sex and education to individuals recruited for groups of ICU Survivors.Those healthy people will also take the examination of brain fMRI,blood inflammatory markers and cognitive assessment.

Conditions

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Cognitive Impairment Functional Magnetic Resonance Imaging Septic Shock Inflammation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU Survivors

sepsis/septic shock Patients with high risk of cognitive impairment who discharge from ICU

No interventions assigned to this group

Healthy Control

The control group have to be medically and cognitively healthy. These individuals are recruited from the community and all attempts will be made to match them on age,sex and education to individuals recruited for groups of ICU Survivors.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

ICU sepsis/septic shock Survivors

* Men and women older than 18;education years≄6(could speak, read, and write);Hospitalized in the ICU more than 2 days and already discharge from ICU;

Exclusion Criteria

* MRI incompatibility;History of neurological disease(diagnosis of depression, schizophrenia, epilepsy, Parkinson's disease, Alzheimer's disease, demyelinating disease, cerebrovascular disease,etc);Severe brain injury;History of alcohol and drug addiction;use of psychotropic medications such as sleeping pills, selective serotonin reuptake inhibitors,etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jian-jun Yang

OTHER

Sponsor Role lead

Responsible Party

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Jian-jun Yang

Director,Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mu huo Ji, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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Jiangyin People's Hospital

Jiangyin, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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20190510

Identifier Type: -

Identifier Source: org_study_id

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