Establishment of a Cohort of Patients With Sepsis-associated Encephalopathy (SAE)

Study Overview
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Brief Summary
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In this study, the researcher involved the sepsis patients(defined by sepsis 3.0) in Peking Union Medical College Hospital. The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 and the Non-SAE group GCS = 15. The control group was the non-infectious patients with acute disease strikes and the healthy control. After the sample collection, the RNA-sequence, metabolites and cytokines were under detection.

Detailed Description
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We conducted a prospective observational cohort study of critically ill patients admitted to Emergency Department at a tertiary care hospital. This clinical study was approved by the Ethics Institutional Review Board of Peking Union Medical College Hospital. We identified the sepsis patients according to the Sepsis 3.0 criteria. The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 and the Non-SAE group GCS = 15. The control group was the non-infectious patients with acute disease strikes and the healthy control. We are collecting the samples of the included participants, including whole blood, plasma, serum, cerebrospinal fluid, stool and rectal swabs. The total RNA was extracted from the whole blood by PAXgene Blood RNA MDx kit (PreAnalytiX) for RNA sequence. We used the Ultra-high performance liquid chromatography-MS/MS (UHPLC-MS/MS) analysis for detected metabolites. We used the Bio-Plex 200 system (Luminex Corporation, Austin, TX, USA) and Simoa HD-X AnalyzerTM (Quanterix) platform to detect cytokines.

Official Title
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Peking Union Medical College Hospital

Conditions
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Sepsis-Associated Encephalopathy

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: sepsis 3.0 diagnostic criteria; Estimated length of hospital stay> 24h; ages 18-89; Acute brain dysfunction: delirium, coma, epilepsy, focal neurological deficit; Patients who meet the non-infectious SIRS diagnostic criteria Exclusion criteria: Diagnosis of patients with brain injury before admission, including Alzheimer's disease, craniocerebral injury, etc .; Primary brain injury (cerebral hemorrhage, cerebral infarction, etc.), secondary brain injury (liver brain, lung brain, uremia encephalopathy, pancreatic encephalopathy, metabolic encephalopathy, Wake encephalopathy, etc.); pregnant and lactating women; Those who have undergone bypass surgery in the past 3 months; Hearing and vision impairment; mental illness and melanoma; Abnormal coagulation, active bleeding Patients with infection at lumbar puncture site Meningeal leukemia patients Patients with other types of encephalopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sepsis associated encephalopathy (SAE)<br>This study is an observational study without drug and other interventions The SAE was defined as the Glasgow Coma Scale (GCS) score of less than 15 | Other: No intervention<br>* No intervention<br>|
| Non-SAE<br>This study is an observational study without drug and other interventions Non-SAE group GCS = 15 | Other: No intervention<br>* No intervention<br>|
| Control<br>This study is an observational study without drug and other interventions The control group was the emergency department patients with acute disease strikes, including heart attack, infraction, and healthy control. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finding the pathogenesis of sepsis encephalopathy | To find the pathogenesis of sepsis encephalopathy by genetic testing of blood and cerebrospinal fluid in patients with sepsis and sepsis and SIRS by molecular biomarkers and physiological parameters | 2020-2030 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis-associated encephalopathy