Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of patients with catheter related complications
研究概览
简要总结
Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.
(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)
详细描述
Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.
(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients admitted to the Access Center at Danderyd who need an elective CVC (surgery, infection, nutrition, medication...)
- •Fully recognize and understand patient information
- •Signed informed consent
排除标准
- •If CVC present prior to inclusion in the study and no intention to change the present CVC over guidewire
- •Age < 18 years
- •Pregnant women
- •Known allergy to gold, silver and palladium
- •Participation in other clinical studies which may interfere with this study as judged by the Investigator
结局指标
主要结局
Number of patients with catheter related complications
时间窗: From CVC insertion until CVC withdrawal
Patients having any complication specified as secondary endpoints
次要结局
- Number of patients with stop or slower flow in any CVC lumen(From CVC insertion until CVC withdrawal)
- Number of patients with device malfunctions(From CVC insertion until CVC withdrawal)
- Number of patients with local thrombosis(From CVC insertion until CVC withdrawal)
- Number of patients with adverse events(From CVC insertion until CVC withdrawal)
- Number of patients with CRI(From CVC insertion until CVC withdrawal)
- Number of patients with CRBSI(From CVC insertion until CVC withdrawal)
- Number of CVC exchanges per patient due to suspected infection or thrombosis(From CVC insertion until CVC withdrawal)
- Number of patients with local CVC infections(From CVC insertion until CVC withdrawal)
- Number of patients with antibiotics and antithrombotics drug use(From CVC insertion until CVC withdrawal)