Mechanism of Cognitive Impairment in ICU Sepsis/Septic Shock Survivors :a Study Using Resting-stage fMRI Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Brief assessment of cognitive impairment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Brief assessment of cognitive impairment
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Jian-jun Yang
Director,Department of Anesthesiology
Zhongda Hospital