Correlation of Formyl Peptide Receptor 1 With Sepsis-related Encephalopathy

NCT05451537 | Unknown

• 1 other identifier: KYLL-2022-0139
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The pathogenesis of sepsis-associated encephalopathy (SAE) is unclear, Formylpeptide receptor 1 (FPR1) is a cell membrane receptor that recruits leukocytes and mediates inflammatory responses after activation, but its role and mechanism in SAE are unknown. This project intends to clarify the relationship between FPR1 activation and SAE from the clinical. The investigators enrolled 100 patients with sepsis in ICU. Patients were divided into two groups according to diagnostic criteria: SAE group and none-SAE group. Whole blood was collected. The serum FPR1 protein level was measured using a commercial enzyme-linked immunosorbent assay. After whole blood RNA was extracted, the expressions of FPR1 and a reference gene were quantified by an automated one-step Taqman RT-PCR assay. Multiple logistical regression analysis was used to identify the independent factors (including FPR1 activation) for the prediction of SAE outcomes.

Conditions

Sepsis-Associated Encephalopathy

Outcome Measures

Primary Outcomes (1)

• The comparison of FPR1 levels in patients with and without sepsis related encephalopathy

  The comparison of serum FPR1 protein levels (ng/ml) in patients with and without sepsis related encephalopathy

  3 days

Secondary Outcomes (3)

• The comparison of Inflammatory cytokines levels in patients with and without sepsis related encephalopathy

  3 days

• The comparison of peripheral blood leukocytes in patients with and without sepsis related encephalopathy

  3 days

• The comparison of S-100β levels in patients with and without sepsis related encephalopathy

  3 days

Study Arms (2)

Sepsis associated encephalopathy group

Patients were diagnosed with sepsis related encephalopathy

None sepsis associated encephalopathy group

Patients were not diagnosed with sepsis related encephalopathy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe sepsis and septic shock, Sepsis associated encephalopathy

You may not qualify if:

• Patients were excluded from the study if they had a previous diagnosis of a neuropsychiatric disease (head trauma, cerebral stroke, epilepsy, and intracranial infection), current brain disorders (hepatic encephalopathy, pulmonary encephalopathy, and severe electrolyte imbalance), concurrent hematologic diseases, malignant tumor, postcardiac arrest, or melanoma or if they were undergoing cancer chemotherapy.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

Department of Anesthesiology, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

Sepsis-Associated Encephalopathy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Gang Ma, doctor

CONTACT

13709519220; magang2671@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 11, 2022
• Study Start: September 1, 2022
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: July 11, 2022

Record last verified: 2022-06

Locations

CN (1)