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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2030-01-14

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.

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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.

Conditions

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Sepsis-Associated Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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sepsis associated encephalopathy (SAE)

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

No intervention

Intervention Type OTHER

No intervention

Non-SAE

This study is an observational study without drug and other interventions Non-SAE group GCS = 15

No intervention

Intervention Type OTHER

No intervention

Control

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.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. sepsis 3.0 diagnostic criteria;
2. Estimated length of hospital stay\> 24h;
3. ages 18-89;
4. Acute brain dysfunction: delirium, coma, epilepsy, focal neurological deficit;
5. Patients who meet the non-infectious SIRS diagnostic criteria

Exclusion Criteria

1. Diagnosis of patients with brain injury before admission, including Alzheimer's disease, craniocerebral injury, etc .;
2. Primary brain injury (cerebral hemorrhage, cerebral infarction, etc.), secondary brain injury (liver brain, lung brain, uremia encephalopathy, pancreatic encephalopathy, metabolic encephalopathy, Wake encephalopathy, etc.);
3. pregnant and lactating women;
4. Those who have undergone bypass surgery in the past 3 months;
5. Hearing and vision impairment;
6. mental illness and melanoma;
7. Abnormal coagulation, active bleeding
8. Patients with infection at lumbar puncture site
9. Meningeal leukemia patients
10. Patients with other types of encephalopathy

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No