NCT06142162招募中不适用
To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers
The Republican Research and Practical Center for Epidemiology and Microbiology1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2021年7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
- 124
- 试验地点
- 1
- 主要终点
- genes polymorphism
研究概览
简要总结
Current study evaluates the relationship between cell immunity, biochemical and genetic markers in patients with sepsis in order to develop algorithm for predicting the course and outcome of severe bacterial infections.
详细描述
- To study the state of the immune system in patients with sepsis: the content of blood monocyte subpopulations (classical, intermediate and non-classical monocytes), HLA-DR expression on monocytes, CD64 expression on neutrophils, spontaneous and stimulated production of reactive oxygen species by blood neutrophils etc.;
- To study biochemical blood parameters and genetic polymorphism of immune response genes;
- To evaluate the relationship between genetic features of the patient's immune system, biochemical blood parameters, immune system cells and the severity of the pathological process.
- To develop an algorithm to prevent the development of sepsis in children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA> 2); availability of written informed consent of the patient's legal representatives for the study.
排除标准
- •acute and chronic heart failure; renal failure; acute and chronic liver failure; acute and chronic leukemia, severe anemia; HIV infection; immunosuppressive therapy; malignant neoplasms
结局指标
主要结局
genes polymorphism
时间窗: 3 years
TNF-α, LTA, IL-4, IL-6, IL-8, IL-10, TLR-2, TLR-4 genes polymorphism
monocytes
时间窗: 3 years
proportion of classical monocytes (CD14++CD16-), intermediate monocytes (CD14++CD16+) and non-classical monocytes (CD14+/-CD16++); HLA-DR level of expression
neutrophils
时间窗: 3 years
percentage of CD64+ neutrophils and CD64 level of expression
cytokines levels in the serum
时间窗: 3 years
TNF-α, LPS, IL-2, IL-4, IL-6, IL-8, IL-10 levels in the serum
次要结局
未报告次要终点
研究者
研究点 (1)
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