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
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
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
Parallel
Tunneled cuffed catheter (TCC) will be implanted for chronic haemodialysis treatment
DeviceIn 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
Procedure/SurgeryIn 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)
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