A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- diagnostic value of PCT
研究概览
简要总结
Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity. The diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. The prospective DIRT study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection.
The study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •device associated infections
排除标准
- •malignancy
- •cytostatic or immunomodulating therapy
结局指标
主要结局
diagnostic value of PCT
时间窗: pre-intervention/procedure/surgery. i.e. at the time of CIED explantation. Measurement of PCT as an biomarker revealing the acute infection (like a sepsis marker)
diagnostic value of PCT in differentiating local pocket infection from infection-free controls and calculated the sensitivity and specificity of the pre-established cut-off value of 0.05 ng/ml
次要结局
未报告次要终点