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

Peking Union Medical College Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis-Associated Encephalopathy
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Yi Li, Medical PhD; Phone Number: 86-0-13693109826; Email: billliyi@126.com

Study Locations

• China
  • Beijing Shi
    • Beijing, Beijing Shi, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yi Li; Phone Number: 13693109826; Email: billliyi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No intervention
Non-SAE; This study is an observational study without drug and other interventions Non-SAE group GCS = 15	Other: No intervention; 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; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yi Li, MD

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 14, 2030

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Sepsis-associated encephalopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Brain Diseases; Sepsis-Associated Encephalopathy
• Other Study ID Numbers: ZS-2165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No