About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tunneled cuffed catheter (TCC) will be implanted for chronic haemodialysis treatment
- Arteriovenous fistula creation for chronic haemodialysis treatment