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Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
Sponsor: Medical University of Vienna
Summary
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
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2026-08-01
Completion Date
2030-12-31
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
Tunneled cuffed catheter (TCC) will be implanted for chronic haemodialysis treatment
In this study we will compare TCCs with arteriovenous fistulas. In our hypothesis, TCCs will be superior to arteriovenous fistulas , because incidence of the main disadvantages of TCC, infection and low flow rates, have been reduced significantly since implantation techniques and product quality of TCC, hygiene protocols and lock solutions for TCC have steadily been improved over the last decade.
Arteriovenous fistula creation for chronic haemodialysis treatment
In this arm arteriovenous fistulas will be created for chronic haemodialysis treatment.