Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Mult… (NCT07649083) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
220 participantsStarted 2026-08-01
Plain-language 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
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing tunneled cuffed catheters to arteriovenous fistulae specifically in elderly or multimorbid patients — given my age or health conditions, does my doctor think I fall into the type of patient this study is designed for, and would either of those access options be appropriate for my situation?
2The trial is measuring access-related complications like loss of access, infection, and thrombosis as its main outcome — based on what's already known about catheters versus fistulae in patients like me, how does my doctor weigh those specific risks for me personally?
3Since this trial is listed as 'not yet recruiting,' how long might it be before it opens, and should I be making a hemodialysis access decision now rather than waiting to see if I could participate?
4This study has no listed phase, which suggests it may be more of a comparative effectiveness study than a drug trial — can my doctor explain what that means for what participants might experience, and whether it differs much from standard care decisions already being made?
5If I were to discuss this trial with my care team, would standard guidelines already favor one access type over the other for someone with my specific health profile, or is there genuinely clinical uncertainty that makes a study like this relevant to my decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The composite primary end-point is any access related complication (loss of access, infection and/or thrombosis)
Timeframe: From enrollment to the end of treatment at 52 weeks