Cohort of patients with sepsis-associated encephalopathy

Peking Union Medical College Hospital

This study is trying to learn more about critically ill patients with sepsis-associated brain problems by collecting samples and comparing them to healthy people and those with other illnesses.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04230447 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a cohort of critically ill patients diagnosed with sepsis-associated encephalopathy (SAE) at Peking Union Medical College Hospital. Patients are identified based on the Sepsis 3.0 criteria, with those exhibiting a Glasgow Coma Scale (GCS) score of less than 15 classified as having SAE. The study includes sample collection of whole blood, plasma, serum, cerebrospinal fluid, and other biological materials for RNA sequencing, metabolite analysis, and cytokine detection. Control groups consist of non-infectious patients with acute diseases and healthy individuals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-89 who meet the Sepsis 3.0 diagnostic criteria and exhibit acute brain dysfunction.

Not a fit: Patients with pre-existing brain injuries or other types of encephalopathy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of sepsis-associated encephalopathy and lead to improved diagnostic and therapeutic strategies for affected patients.

How similar studies have performed: While there is ongoing research in sepsis and its neurological impacts, this specific cohort study approach is relatively novel.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yi Li, Medical PhD

Conditions Sepsis-Associated Encephalopathy; Sepsis-associated encephalopathy