NCT04230447

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

Peking Union Medical College Hospital

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Yi Li, MD · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis-Associated Encephalopathy

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-11-01
• Completion: 2030-01-14
• First posted: 2020-01-18
• Last updated: 2023-06-15

Locations

1 site across 1 country: China