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

NCT04230447 | Recruiting

• 1 other identifier: ZS-2165
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis-Associated Encephalopathy

Keywords

Sepsis-associated encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Other: No intervention

Non-SAE

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

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Control; Non-SAE; sepsis associated encephalopathy (SAE)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Meet the above three categories of patients consistent with inclusion and exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi Li, MD: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Qin M, Yu S, Lu X, Gong C, Song Z, Zhu H, Gao Y, Li Y. Reduced phosphatidylcholine and phosphatidylethanolamine levels correlate with inflammatory activation in sepsis-associated encephalopathy. Eur J Med Res. 2025 Aug 31;30(1):828. doi: 10.1186/s40001-025-03115-z.

  PMID: 40887666 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We are collecting the samples of the included participants, including whole blood, plasma, serum, cerebrospinal fluid, stool and rectal swabs.After the sample collection, the RNA-sequence, metabolites and cytokines were under detection.

MeSH Terms

Conditions

Sepsis-Associated Encephalopathy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Yi Li, Medical PhD

CONTACT

86-0-13693109826; billliyi@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director billliyi@126.com

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: February 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 14, 2030
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)