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Recruiting NCT04230447

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

— Observational Sepsis-Associated Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Sepsis-Associated Encephalopathy. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Peking Union Medical College Hospital

Overview

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

  • Other No intervention
    No intervention

Primary outcome measures

  • Finding the pathogenesis of sepsis encephalopathy [Time frame: 2020-2030]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Publications

  • 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

Identifiers

NCT: NCT04230447 · ZS-2165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗