NCT02922998已完成不适用
Monitoring CD64 on Neutrophils Regarding Effects of Antibiotics in Patients With SIRS Developing Sepsis
University of Ulm1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- CD64 expression on neutrophils measured by LeukoDx
研究概览
简要总结
The purpose of the study is to find out whether CD64 expression on neutrophils measured by a new bedside test (LeukoDx) within 30 minutes is associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis.
详细描述
In the present study, in critically ill patients with suspected infection undergoing application of antibiotics, CD64 and inflammatory plasma markers will be determined on days 1 to 4.
CD64 expression on the surface of neutrophils will be determined by fluorescence activated cell sorter (FACS) and with a new bedside test (LeukoDx).
The purpose of the study is to clarify:
- Is CD64 expression on neutrophils associated with effective antibiotic therapy in critically ill adult patients at risk of sepsis?
- Is CD64 expression associated with distinct plasma parameters of inflammation?
- Do the results of the gold standard CD64 determination by FACS correlate with those of a new bedside test (LeukoDx)?
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •critically ill adult patients
- •initiation of antibiotic treatment
- •patients < 48 hours after admission on ICU
排除标准
- •multiple admissions on ICU, (>1 in last 2 weeks period)
- •leukopenia < 1 G/l
- •and thrombocytopenia
- •rhG-CSF or IFN-gamma therapy up to 1 week before inclusion
- •participation in another study receiving drugs or biological within the preceeding 30 days
- •recent longterm corticosteroid treatment
- •patients after organ transplantation treated with immunomodulating drugs
- •pregnant patients or after delivery
- •life expectancy < 24 hours
- •polytraumatized patients with reanimation on scene, or infest prognosis
- •patients under high dose corticosteroids or chemotherapy
结局指标
主要结局
CD64 expression on neutrophils measured by LeukoDx
时间窗: 1 year
次要结局
- Association of course of CD64 expression with effective antibiotic treatment(1 year)
研究者
Manfred Weiss
Professor, MD
University of Ulm
研究点 (1)
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