Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter for Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 7
- 主要终点
- Primary Endpoint: Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months
研究概览
简要总结
The purpose of this study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement.
详细描述
The CentrosFLO™ Tunneled Dialysis Catheter is a 15F dual-lumen, double-D shaped catheter similar to other "split tip" catheters in the market: outflow ("arterial") and return ("venous") lumens that separate, a subcutaneous Dacron® cuff, extension sets with clamps and caps, and construction from Carbothane® material. The CentrosFLO™ catheter contains two small pressure-relief holes near the tips.
The main difference of the CentrosFLO catheter is in the design of the tip. Current "split tip" catheters have two free ends that diverge, but are each essentially straight segments. In the CentrosFLO catheter the arterial lumen bends in an arc back towards the venous lumen, and the venous lumen bends towards the arterial lumen. As a result, the catheter has two curved surfaces that will rest against the vena cava wall to automatically "center" the catheter within the vein. The contact points of the catheter against the vena cava wall should be smaller and more disperse than with current straight-tip or split catheters. The following drawing demonstrates the design of the catheter, showing the current recommendation that the arterial port always be to the left.
The goal of the study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement. The investigators plan to enroll 10 patients in the study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who are initiating or continuing in-center intermittent hemodialysis who are scheduled to receive a tunneled dialysis catheter in the right or left internal jugular vein
- •The patients may have had a prior tunneled catheter for dialysis in the right IJ site.
- •Patients will be expected to need use of the catheter for more than 45 days
排除标准
- •Patients in whom the catheter is planned to be placed into the same site as an existing catheter, by over-the-wire catheter exchange
- •Patients unable to give informed consent
结局指标
主要结局
Primary Endpoint: Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months
时间窗: 1.5 years
Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months
次要结局
- Secondary Endpoint: Incidence of patency failure defined as blood flow rate below 300 mL/min or removal of catheter for failure of flow at any time during the study.(1.5 years)