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临床试验/NCT02347592
NCT02347592已完成不适用

Comparison of Self-locating Catheter Versus a Straight Catheter for Outflow Problems.

University Hospital, Umeå1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2007年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
insufficient drainage/flow of dialysis fluid that unabled adequate dialysis

研究概览

简要总结

The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The investigators used these catheters in parallel for several years. To clarify what catheter has least problems the investigators performed a comparative study to clarify if outflow problems differed between these catheters.

详细描述

The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD). A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo. The investigators had used both in parallel for several years. To clarify what catheter to focus on in the future the investigators performed a comparative study to clarify if outflow problems differed between these catheters.

Study design: interventional and randomized at the same hospital Patients: Patients that were planned to start PD were informed and asked to participate in the randomized study. All patients who were asked accepted and consented to be included in the investigation.

At the investigators hospital, insertion of pertitnoean dialysis catheters is performed by open surgery. This is performed using a three layer suture technique performed in local anesthesia. The technique enables immediate start of dialysis after surgery.

Outflow problems were defined as a delay of flow of more than 40 minutes for 500ml of PD fluid.

The duration of time was calculated by months on PD. Patients who died, were transplanted or changed for hemodialysis were censored. End-point was an insufficient drainage/flow of dialysis fluid that unabled adequate dialysis and intervention (by surgery) was necessary to correct/change catheter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
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 consecutive patients that are eligible and planned to start peritoneal dialysis and thereafter accept to be part of the study.

排除标准

  • 未提供

结局指标

主要结局

insufficient drainage/flow of dialysis fluid that unabled adequate dialysis

时间窗: 12 Months

次要结局

未报告次要终点

研究者

发起方
University Hospital, Umeå
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bernd Stegmayr

Professor

University Hospital, Umeå

研究点 (1)

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