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临床试验/NCT07649083
NCT07649083尚未招募不适用

Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients

Medical University of Vienna0 个研究点目标入组 220 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
220
主要终点
The composite primary end-point is any access related complication (loss of access, infection and/or thrombosis)

研究概览

简要总结

Patients are randomly assigned to a study group. Depending on the study group, either an arteriovenous fistula or tunneled cuffed catheter (TCC) will be implanted, followed by continuous evaluation of the patients during the first year after initiating the vascular access. The evaluation includes statistical evaluation of all events, including loss of access, thrombosis, infection, loss of patency, increase in co-morbidities, e.g. congestive heart failure as well as quality of life. The implantation of the TCC is a standard procedure and it will be used only in accordance with the approved instructions of use on subjects who have signed an informed consent form. The surgery is a standard operation and it will be performed by specialized surgeons on subjects who have signed an informed consent form (No grafts will be used; implantation of a standard TCC, used at the Department of Nephrology). Both, an arteriovenous fistula or a TCC, will be used for routine chronic haemodialysis

详细描述

Patients with diagnosed end stage kidney disease and indication for chronic dialysis rely on a well-functioning access for dialysis. For long term haemodialysis there are three possibilities: arteriovenous fistulae, arteriovenous grafts and tunneled cuffed catheters. For the last decades, the preferred form of vascular access for every eligible patient was based on the "Fistula First Breakthrough Initiative", nowadays NVAII (National Vascular Access Improvement Initiative), implemented by the US-American CMS (Centers for Medicare & Medicaid Services). Although the "fistula first" dogma evolved to the more patient-centered recommendation "right access, for the right patient, at the right time for the right reasons" of the latest KDOQI guidelines from 2019, fistula still is seen as the "better" access compared with tunneled catheters whenever possible. The generally low quality of catheter care in previous retrospective publications make meaningful comparisons between fistula and catheter populations difficult. There are no prospective studies on this subject so far. In this study, we address differences between two dialysis vascular access types in elderly (Age 60 and older) and/or multimorbid patients (Charlson Comorbidity Index score of >6)

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥60 years or <60 years with a CCI Score >6
  • Patients with CKD G5 A1-3 with indication for hemodialysis
  • Stable clinical condition
  • Eligibility for both arteriovenous fistula on the upper extremities and TCC
  • Availability for follow-up
  • Written informed consent

排除标准

  • Uncontrolled infection and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening
  • Poor overall health or malignancy not in remission at screening
  • Major surgery within 12 weeks before screening
  • Pre-existent vascular access
  • Patient not eligible for any one of the vascular access options
  • Endovascular arteriovenous fistula

研究组 & 干预措施

Arteriovenous fistula creation for chronic haemodialysis treatment

Active Comparator

干预措施: Arteriovenous fistula creation for chronic haemodialysis treatment (Procedure)

Tunneled cuffed catheter insertion for chronic haemodialysis treatment

Experimental

干预措施: Tunneled cuffed catheter (TCC) will be implanted for chronic haemodialysis treatment (Device)

结局指标

主要结局

The composite primary end-point is any access related complication (loss of access, infection and/or thrombosis)

时间窗: From enrollment to the end of treatment at 52 weeks

次要结局

未报告次要终点

研究者

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

Guerkan SENGOELGE

Assoc. Prof. Priv.-Doz. Dr. med.univ.

Medical University of Vienna

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