An interventional study of Tunneled cuffed catheter (TCC) will be implanted for chronic haemodialysis treatment and Arteriovenous fistula creation for chronic haemodialysis treatment in End Stage Renal Failure, Hemodialysis, Vascular Access and Fistulas Arteriovenous, sponsored by Medical University of Vienna. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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
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)
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 220 is above the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
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Procedure: Arteriovenous fistula creation for chronic haemodialysis treatment
Device: 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.
In this arm arteriovenous fistulas will be created for chronic haemodialysis treatment.
The composite primary end-point is any access related complication (loss of access, infection and/or thrombosis)
Time frame: From enrollment to the end of treatment at 52 weeks
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna