Co-inhibitory Molecules on Treg and miR-155-5p in Patients With Sepsis

Recruiting

• Conditions: 28 Day Mortality
• Interventions: Other: no intervention

• Registration Number: NCT05126537
• Lead Sponsor: Southeast University, China

Brief Summary

there is high mortality rate of sepsis, 36% in 90-days of sepsis in China, and there is no effective treatment. Immunosuppression mediated by sepsis is an important cause of death in patients. Treg cells are important immunomodulatory cell. Treg's over-differentiation is involved in the development of sepsis induced immunosuppression. In sepsis patients, the expression of PD-1、CTLA-4 and TIGIT on Treg cell surface increased, and Treg cells with high expression of co-inhibitory molecules showed stronger immunosuppressive characteristics. MiR-155-5p is an unencoded RNA transcript from a proto-oncogene B cell integration cluster. In sepsis, the expression of miR-155 increased in peripheral blood and correlated with the patient's prognosis. Recent studies have shown that miR-155-5p promotes co-inhibitory molecules expressed on T cells in LCMV infected animal models. However, the relationship between the expression of peripheral blood miR-155-5p in sepsis patients and the expression of co-inhibitory molecules on Treg cell surface is not clear.

Detailed Description

1. peripheral blood Treg cells and their surface PD-1、CTLA-4 and TIGIT levels in sepsis patients were measured by flowcytometry. SOFA score、APACHE II score were recorded

2. the level of miR-155-5p were measured by RT-qPCR in patients with sepsis on day 0-1 and day 3-5, and the correlation between the expression of the co-inhibitory molecules and miR-155-5p were evaluated

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-19
• Study Start: 2022-01-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• sepsis 3.0 diagnositic criteria are met. older than 18 years old. total course is less than 7 days. Informed consent is obatained.

Exclusion Criteria

• pregnancy. patients with active malignant tumors. chronic hepatitis or HIV. patients under treatment with immunosuppressive drugs (except patients with glucocorticosteroid prednisone or equivalent dose<10 mg/d per day)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis patients	no intervention	Sepsis patients as study group
Health volunteers	no intervention	Health volunteers as control group
ICU non-sepsis patients	no intervention	ICU non-sepsis patients as control group

Primary Outcome Measures

Name	Time	Method
28 day mortality	28 days	all patients followed up to 28 days

Trial Locations

Locations (1)

Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China