Hematological Infection Profile (ICIS/ICPS) Compared to Actual Best Hospital Practice for Differentiation of SIRS and Sepsis and Management of Antiinfective Therapy in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- The primary objective of this study performed according to an observational post-ad-hoc design is to show that the two Sysmex infection scores provide a better performance than CRP & PCT for infection processes thus providing an efficient alternative.
研究概览
简要总结
CRP and PCT are not valid parameters of early infection in particularly postoperative patients. (Sanders et al., A&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol 15.2) Better detection systems for SIRS and sepsis are urgently required.
ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic score) are two new score-systems depending on detectable cellular response of the innate immune system in human peripheral blood.
The purpose of this observational study is to determine if these scores are superior in early differentiation between non-infectious SIRS and infectious SIRS (sepsis) in postoperative patients. Furthermore, the applicability of the scores for triggering start and ending of anti-infective therapy will be examined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •all ICU patients age > 18 years
- •more than 36h on ICU
排除标准
- •ICU patients age < 18 years
- •less than 36h on ICU
结局指标
主要结局
The primary objective of this study performed according to an observational post-ad-hoc design is to show that the two Sysmex infection scores provide a better performance than CRP & PCT for infection processes thus providing an efficient alternative.
时间窗: a period of 60 days
Approximately 200 patients will be enrolled in the study. They are followed up until the end of ICU stay or, for a maximum of 60 days. Usually in clinical routine, patients suspected to have an infection process, receive once per day a "full infectiology profile". It consists of CRP, PCT and the Sysmex infection profiles (ICIS/ICPS).
次要结局
- The second objective is to investigate whether ICIS® and ICPS® could assist in faster antiinfective regim decisions than CRP & PCT.(a period of 60 day)
研究者
Claudia Spies
Univ. Prof. Dr. med. Claudia Spies
Charite University, Berlin, Germany