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Clinical Trials/NCT03946839
NCT03946839
Completed
Not Applicable

Mechanism of Cognitive Impairment in ICU Sepsis/Septic Shock Survivors :a Study Using Resting-stage fMRI Technique

Jian-jun Yang1 site in 1 country40 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
Jian-jun Yang
Enrollment
40
Locations
1
Primary Endpoint
Brief assessment of cognitive impairment
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
January 20, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Jian-jun Yang
Responsible Party
Sponsor Investigator
Principal Investigator

Jian-jun Yang

Director,Department of Anesthesiology

Zhongda Hospital

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.

Outcomes

Primary Outcomes

Brief assessment of cognitive impairment

Time Frame: 1.5 h before fMRI examination

Cognitive impairment assessed with help of MMSE(Mini-mental State Examination).The MMSE has 5 scaled scores; the scores are weighted sums of the questions in each section. The 5 sections and their range of score are listed below:Orientation 0-10;Registration 0-3;Attention and calculation 0-5;Recall 0-3;Language 0-9.Total score range from 0-30. Lower scores = more disability, higher scores = less disability.

Resting-state functional magnetic resonance imaging results

Time Frame: Up to 1 month after ICU discharge(It was judged by the doctor in charge according to the patient's recovery)

3D T1-weighted magnetization parameters: TR/TE/flip angle = 7.2 ms/min full/8; FOV = 256 mm; 312 slices; slice thickness = 1 mm. For the BOLD sequence, a series of 35 interleaved transversal slices were acquired for full-brain coverage with a gradient-echo based, echo planar imaging (EPI) sequence with the following parameters: TR/TE/ flip angle = 2000 ms/30 ms/90; FOV = 224 mm; slice thickness = 4.0 mm.

Blood inflammatory markers

Time Frame: 2h before taking fMRI examination

2-4 ml of blood was drawn for blood inflammatory markers(IL-1β,IL-2R,IL-6,IL-8,TNF-α) detection.

Secondary Outcomes

  • Specific assessment of cognitive impairment 3(1.5h before taking fMRI examination)
  • Blood markers(the same day with fMRI examination(2h before taking fMRI examination))
  • Specific assessment of cognitive impairment 4(1.5h before taking fMRI examination)
  • Specific assessment of cognitive impairment 5(1.5h before taking fMRI examination)
  • Specific assessment of cognitive impairment 6(1.5h before taking fMRI examination)
  • Assessment of cognitive impairment(1.5h before taking fMRI examination)
  • Specific assessment of cognitive impairment 1(1.5h before taking fMRI examination)
  • Specific assessment of cognitive impairment 2(1.5h before taking fMRI examination)
  • Specific assessment of cognitive impairment 7(1.5h before taking fMRI examination)
  • Assessment of Depression(1.5h before taking fMRI examination)

Study Sites (1)

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