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临床试验/NCT01649102
NCT01649102已完成4 期

Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients

AZ Sint-Jan AV2 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
302
试验地点
2
主要终点
overall catheter survival rate

研究概览

简要总结

The trial aims to compare the performance of two tunneled cuffed catheters (TCC) in chronic hemodialysis patients. The design of the catheter may affect the propensity for thrombosis and hence intraluminal infection, as well the percentage of recirculation and hence the efficiency of dialysis.

详细描述

The use of tunneled cuffed catheters (TCCs) as vascular access is discouraged in the NKF DOQI guidelines, because of their propensity for infection, thrombosis, inadequate and/or irregular blood flow rates and damage to large central veins. In addition, emerging data suggest a link between catheter use and cardiovascular morbidity and mortality. Nevertheless, they are still frequently used in the hemodialysis population, either because of documented inadequate vascular access anatomy, or as a bridge to a functional permanent access.

A large number of TCC are available, that mainly differ with respect to material type, lumen diameter and design, tip design, as well as presence and design of side holes. There is currently no proven advantage of one long-term catheter design over another.

The design of the catheter tip may affect the propensity for thrombosis and hence intraluminal infection, as well the percentage of recirculation, especially when arterial and venous blood tubing are reversed. Commonly used catheters have a staggered tip design, meaning that the outflow tip extends several centimetres (typically a minimum of 2.5 cm) beyond the inflow tip, to prevent recirculation. Other designs are a split tip, or a symmetrical tip. In the latter type, used in the Palindrome® (Covidien) catheter, a spiral separator is incorporated allowing either lumen to be used as the arterial port.

Many catheters have multiple side holes, to decrease shear rate and increase flow on the arterial side and reflecting the belief that backup inflow is necessary in the case of obstruction. However, side holes can also promote thrombosis and infection due to the irregularity of their cut surfaces. Especially the distal side holes comprise a low flow zone with an increased clotting risk. The Palindrome® (Covidien) catheter has laser cut side holes, which are thought to have a smoother surface and a lower tendency to cause thrombosis.

Inadequate blood flow in a catheter is often mended by reversal of the inlet and outlet lumens. However, reversal of flow leads to a substantial increase of recirculation (from 2%-3% to 10%), affecting the efficiency of treatment. It should therefore never be used except temporarily until the problem is definitively corrected. The symmetrical tip design of the Palindrome® (Covidien) catheter allows lumen reversal without increased recirculation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • All patients (male or female, age < 18 years) on chronic hemodialysis who require a tunneled cuffed catheter as temporary or definite vascular access are eligible. Written informed consent is required prior to inclusion.

排除标准

  • Pregnancy or breast-feeding
  • Life-expectance of < 6 months due to major co-morbid conditions
  • Inability to provide informed consent
  • Occlusion or inaccessibility of the right internal jugular vein

结局指标

主要结局

overall catheter survival rate

时间窗: 3 years

次要结局

  • Mechanical catheter dysfunction: number of dialysis sessions requiring urokinase administration per 1000 catheter days; number of catheter removals for mechanical obstruction(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. An De Vriese

M.D., Ph. D.

AZ Sint-Jan AV

研究点 (2)

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