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

Sepsis-Associated Encephalopathy Clinical Trial

— SAE  

Official title:

Peking Union Medical College Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230447
• Other study ID #: ZS-2165
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: January 14, 2030

Study information

• Verified date: June 2023
• Source: Peking Union Medical College Hospital
• Contact: Yi Li, Medical PhD
• Phone: 86-0-13693109826
• Email: billliyi[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 14, 2030
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Sepsis
• Sepsis-Associated Encephalopathy

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing Shi

Sponsors (1)

Lead Sponsor	Collaborator
Yi Li, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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