跳至主要内容
临床试验/NCT05126537
NCT05126537招募中不适用

An Observational Study on the Relationship Between Expression of Co-inhibitory Molecules on Treg and miR-155-5p Expression in the Peripheral Blood of Patients With Sepsis

Southeast University, China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
28 day mortality

研究概览

简要总结

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.

详细描述

  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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

28 day mortality

时间窗: 28 days

all patients followed up to 28 days

次要结局

未报告次要终点

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Songqiao Liu

Chief

Southeast University, China

研究点 (1)

Loading locations...

相似试验