Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
1 other identifier
interventional
220
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 16, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
June 16, 2026
June 1, 2026
3.4 years
June 11, 2026
June 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The composite primary end-point is any access related complication (loss of access, infection and/or thrombosis)
From enrollment to the end of treatment at 52 weeks
Study Arms (2)
Arteriovenous fistula creation for chronic haemodialysis treatment
ACTIVE COMPARATORTunneled cuffed catheter insertion for chronic haemodialysis treatment
EXPERIMENTALInterventions
In this arm arteriovenous fistulas will be created 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Vachharajani TJ, Moist LM, Glickman MH, Vazquez MA, Polkinghorne KR, Lok CE, Lee TC. Elderly patients with CKD--dilemmas in dialysis therapy and vascular access. Nat Rev Nephrol. 2014 Feb;10(2):116-22. doi: 10.1038/nrneph.2013.256. Epub 2013 Dec 3.
PMID: 24296629BACKGROUNDLok CE. Fistula first initiative: advantages and pitfalls. Clin J Am Soc Nephrol. 2007 Sep;2(5):1043-53. doi: 10.2215/CJN.01080307. Epub 2007 Aug 16. No abstract available.
PMID: 17702726BACKGROUNDRidao-Cano N, Polo JR, Polo J, Perez-Garcia R, Sanchez M, Gomez-Campdera FJ. Vascular access for dialysis in the elderly. Blood Purif. 2002;20(6):563-8. doi: 10.1159/000066961.
PMID: 12566673BACKGROUNDLok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
PMID: 32778223BACKGROUNDXue JL, Dahl D, Ebben JP, Collins AJ. The association of initial hemodialysis access type with mortality outcomes in elderly Medicare ESRD patients. Am J Kidney Dis. 2003 Nov;42(5):1013-9. doi: 10.1016/j.ajkd.2003.07.004.
PMID: 14582045BACKGROUNDCoresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
PMID: 17986697BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. Priv.-Doz. Dr. med.univ.
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 16, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2030
Last Updated
June 16, 2026
Record last verified: 2026-06