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临床试验/NCT03523260
NCT03523260撤回不适用

High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)

University of Alabama at Birmingham2 个研究点 分布在 1 个国家开始时间: 2013年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Complication rate

研究概览

简要总结

The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare the complication rate and function of the three catheter designs.

详细描述

The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. Participants will be randomized to receive a split-tip, step-tip or symmetric tip catheter in a 1:1:1 ratio. All participants will be followed per their referring physician's standard of care. Information regarding any patient complications will be obtained from Dr. Allon's dialysis patient database (Vascular Access in Hemodialysis Patients, IRB # X980813005). This study will review and compare the complication rate and function of the three catheter designs. There are no studies to our knowledge that compared catheter designs placed specifically via the left internal jugular vein. The investigators hypothesize that because the left internal jugular vein is anatomically more complex than the right one, tunneled dialysis catheters with split-tip design may perform sub-optimally, compared to step-tip and symmetric tip designs, when placed via the left internal jugular vein. If this hypothesis is true, the results of the study may influence future clinical practice and reduce the rates of replacement of catheters placed through the left internal jugular vein, resulting in better patient care and significant cost-savings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing and able to provide a written informed consent
  • 19 years or older
  • Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.
  • Patent left internal jugular vein.
  • Able to read and understand English.

排除标准

  • Previous enrollment in this trial
  • Patients unable or unwilling to provide informed consent
  • Prisoners or incarcerated individuals
  • Women who are pregnant
  • Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated

结局指标

主要结局

Complication rate

时间窗: 1 month

1 month complication rate of left internal jugular vein dialysis catheters

次要结局

  • Complication rate(6 months)
  • Catheter dysfunction(6 months)

研究者

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

Husameddin M El Khudari

Interventional Radiology

University of Alabama at Birmingham

研究点 (2)

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