Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Th2/Th1 upon enrollment
研究概览
简要总结
To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and how it was related to 28 day-prognosis and ICU-acquired infections among critically ill patients of community-acquired severe sepsis with new onset.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years of age and no more than 90 years of age
- •sepsis was defined according to consensus criteria
- •diagnosis of sepsis and complicatied with organ dysfunction no longer than 48 h
- •provided written informed consent.
排除标准
- •diagnosis of hematological,immunological disease or cancer
- •treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization
- •For non-severe sepsis ICU control group:
- •Inclusion Criteria:
- •at least 18 years of age and no more than 90 years of age
- •without diagnosis of sepsis and admitted to ICU
- •provided written informed consent.
- •Exclusion Criteria:
- •diagnosis of hematological,immunological disease or cancer
- •treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization
- •For healthy control group:
- •Inclusion Criteria:
- •at least 18 years of age and no more than 90 years of age
- •provided written informed consent.
- •Exclusion Criteria:
- •diagnosis of hematological,immunological disease or cancer
- •treatment with chemotherapy agents or corticosteroids within 6 months prior to enrollment
结局指标
主要结局
Th2/Th1 upon enrollment
时间窗: Day 0 after enrollment for community-acquired severe sepsis group and Day 0 after enrollment for the non-severe sepsis patients and heathy control group
The blood samples were collected for T helper 1 cells and T helper 2 cells populations measured by flow cytometry. All groups are needed.
Th2/Th1 on Day 3
时间窗: Day 3 after enrollment for community-acquired severe sepsis group
populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.
Th2/Th1 on Day 7
时间窗: Day 7 after enrollment for community-acquired severe sepsis group
populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.
次要结局
- ICU-acquired infection for community-acquired severe sepsis group(28-day)
- 28-day mortality for community-acquired severe sepsis group(28-day)
研究者
Jianfeng Xie
Doctor
Southeast University, China