Clinical trial NCT03946839: Functional Magnetic Resonance Imaging (fMRI) of Brain in ICU Survivors With Cognitive Impairment
Official title: Mechanism of Cognitive Impairment in ICU Sepsis/Septic Shock Survivors :a Study Using Resting-stage fMRI Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Functional Magnetic Resonance Imaging
Septic Shock
Inflammation
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU sepsis/septic shock Survivors of Jiangyin people's Hospital and healthy people from community recruitment

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brief assessment of cognitive impairment
timeFrame: 1.5 h before fMRI examination
measure: Resting-state functional magnetic resonance imaging results
timeFrame: Up to 1 month after ICU discharge(It was judged by the doctor in charge according to the patient's recovery)
measure: Blood inflammatory markers
timeFrame: 2h before taking fMRI examination
Secondary outcomes:
measure: Blood markers
timeFrame: the same day with fMRI examination（2h before taking fMRI examination）
measure: Assessment of cognitive impairment
timeFrame: 1.5h before taking fMRI examination
measure: Specific assessment of cognitive impairment 1
timeFrame: 1.5h before taking fMRI examination
measure: Specific assessment of cognitive impairment 2
timeFrame: 1.5h before taking fMRI examination
measure: Specific assessment of cognitive impairment 3
timeFrame: 1.5h before taking fMRI examination
measure: Specific assessment of cognitive impairment 4
timeFrame: 1.5h before taking fMRI examination
measure: Specific assessment of cognitive impairment 5
timeFrame: 1.5h before taking fMRI examination
measure: Specific assessment of cognitive impairment 6
timeFrame: 1.5h before taking fMRI examination
measure: Specific assessment of cognitive impairment 7
timeFrame: 1.5h before taking fMRI examination
measure: Assessment of Depression
timeFrame: 1.5h before taking fMRI examination
Other outcomes:
Locations:
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Mu huo Ji, PhD
role: PRINCIPAL_INVESTIGATOR
References: