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

NCT03946839 | Completed

• 1 other identifier: 20190510
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Functional Magnetic Resonance Imaging; Septic Shock; Inflammation

Outcome Measures

Primary Outcomes (3)

• Brief assessment of cognitive impairment

  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.

  1.5 h before fMRI examination

• Resting-state functional magnetic resonance imaging results

  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.

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

• Blood inflammatory markers

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

  2h before taking fMRI examination

Secondary Outcomes (10)

• Blood markers

  the same day with fMRI examination（2h 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 3

  1.5h before taking fMRI examination

Study Arms (2)

ICU Survivors

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ICU sepsis/septic shock Survivors of Jiangyin people's Hospital and healthy people from community recruitment

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jian-jun Yang: lead

Study Sites (1)

Jiangyin People's Hospital

Jiangyin, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Shock, Septic; Inflammation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Mu huo Ji, PhD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director,Department of Anesthesiology

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: June 1, 2020
• Primary Completion: November 20, 2023
• Study Completion: January 20, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (1)