Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients

Overview

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

Detailed description

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)

Interventions

• 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.
• Procedure Arteriovenous fistula creation for chronic haemodialysis treatment
  In this arm arteriovenous fistulas will be created for chronic haemodialysis treatment.

Primary outcome measures

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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 24296629
• Lok 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 17702726
• Ridao-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 12566673
• Lok 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 32778223
• Xue 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 14582045
• Coresh 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 17986697

Identifiers

NCT: NCT07649083 · 1656/2016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗