Venous Thromboembolism and Infections Associated With Three Vascular Access Devices in Home Parenteral Nutrition : a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rate of (incidence) symptomatic venous thromboembolism, catheter related infection, and mechanical complications related to central venous access device
研究概览
简要总结
Central vascular access devices are required for home parenteral nutrition (HPN). There is few data available concerning their complications in adult HPN patients, and the potential link between venous thromboembolism and catheter infection is not well established.
The aim of this prospective cohort study is to compare the incidence rate of catheter related complications among 3 types of central vascular access: peripherally inserted central catheters; tunneled catheters and port-a-cath devices, in adults patients on HPN; describe the risk factors, and identify a potential link between venous thromboembolism and infection.
More than 300 patients will be consecutively enrolled and followed up from the time of catheter insertion until its removal. Venous complication (identify by an ultrasound examination if deep vein thrombosis is suspected), infection related to catheter and mechanical complications will be analyzed. The incidence of complications will be expressed per 1000 catheters-day and or as a percentage of total catheter.
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
- •adult patients
- •having a catheter insertion during the study periode
- •at the unit of vascular access of Lyon Sud Hospital
- •for parenteral nutrition
- •from July 1st, 2017 to June 30, 2020
排除标准
- •catheter inserted in intensive care unit
- •for other treatment (chemotherapy, antibiotic)
结局指标
主要结局
Rate of (incidence) symptomatic venous thromboembolism, catheter related infection, and mechanical complications related to central venous access device
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
* Deep vein thrombosis of the upper extremity : suspected if symptomatic (swelling, local pain, edema) and confirmed by venous ultrasound and/or computed tomography * Catheter related bloodstream infection suspected if local inflammation and/or fever, and confirmed by blood sample and/or catheter culture * Mechanical complications (displacement, drop, kink) : described by nurses or patient
次要结局
未报告次要终点