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

Peking Union Medical College Hospital

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04230447
Acronym
SAE
Enrollment
3000
Registered
2020-01-18
Start date
2021-02-01
Completion date
2030-01-14
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-Associated Encephalopathy

Keywords

Sepsis-associated encephalopathy

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.

Detailed 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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Yi Li, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Finding the pathogenesis of sepsis encephalopathy2020-2030To 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

Countries

China

Contacts

Primary ContactYi Li, Medical PhD
billliyi@126.com86-0-13693109826

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026