Randomized Double Blind Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Infection rate
研究概览
简要总结
To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a conventional PICC catheter in a tertiary care patient population. Secondary goals will be to determine if there is a difference between the two catheters with early and late infections, to determine the cost comparison including extra cost of treatment for a line related infection, to determine if there are any non-infectious related complication differences between the two catheters.
详细描述
All patients who are referred to VIR for a PICC line will be evaluated to see if they satisfy the inclusion/exclusion criteria. The study will be discussed with those who do and informed consent will be obtained from those wishing to participate. The patient will then be randomized to one of two types of PICC lines. All lines will be placed by identical technique. This will include sterile technique, placement via a vein of the upper arm using ultrasound guidance, and positioning of the catheter tip under fluoroscopic guidance. A database of all catheters placed will be kept. Records will be reviewed at 1 week, 30 days, and 60 days by the Interventional Radiology Fellow.Review will include length of time catheter was in place, whether treatment was completed, whether catheter was removed prematurely, the clinical reason for removal, results of other imaging tests, and results of cultures on any catheters removed for suspicion of infection. Any non-infectious complications related to the catheter will also be noted. The reviewer will be blinded to which catheter was used during the procedure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 18 years of age
- •Have been scheduled for a medically necessary PICC placement
排除标准
- •Less than 18 years of age
研究组 & 干预措施
Antibiotic coated PICC
Cook Medical Spectrum Turbo-Ject Minocycline/Rifampin Power-Injectable PICC (5fr double lumen or 6fr triple lumen)
干预措施: PICC (Cook, Bard) (Device)
Non-antibiotic coated PICC
Bard Access PowerPICC Power Injection PICCs (6fr double lumen or 6fr. triple lumen)
干预措施: PICC (Cook, Bard) (Device)
结局指标
主要结局
Infection rate
时间窗: 60 days
Records will be reviewed up to 60 days post PICC line procedure to assess whether catheter was removed prematurely for infection and results of cultures on any catheters removed.
次要结局
未报告次要终点
