Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arteriovenous fistula creation for chronic haemodialysis treatment | Active Comparator |
| |
| Tunneled cuffed catheter insertion for chronic haemodialysis treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tunneled cuffed catheter (TCC) will be implanted for chronic haemodialysis treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gürkan Sengölge, Assoc. Prof | Contact | +43 1 40400 43890 | guerkan.sengoelge@meduniwien.ac.at |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24296629 | Background | 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. | |
| 17702726 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Arteriovenous fistula creation for chronic haemodialysis treatment | Procedure | In this arm arteriovenous fistulas will be created for chronic haemodialysis treatment. |
|
| 12566673 | Background | 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. |
| 32778223 | Background | 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. |
| 14582045 | Background | 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. |
| 17986697 | Background | 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. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided