AUSTrian Randomized Interventional Study on Dialysis Accesses

Study Overview
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Brief Summary
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Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a fistula first approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index >6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.

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

Conditions
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End Stage Renal Disease, Catheter Infection, Shunt Malfunction

Intervention / Treatment
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* Device: Arteriovenous Fistula
* Device: Tunneled Cuffed Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 60 and higher CCI Score >6 when under 60 years Patients with CKD G5 A1-3 with indication for hemodialysis Stable clinical condition Eligibility for both arteriovenous fistula on the upper extremitiesandTCC Availability for follow-up. Written informed consent. Exclusion Criteria: Uncontrolled infection at screening and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening. Poor general condition of 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arteriovenous fistula<br> | Device: Arteriovenous Fistula<br>* Surgical implantation of an arteriovenous fistula for hemodialysis<br>|
| Experimental: Tunneled Cuffed Catheter<br> | Device: Tunneled Cuffed Catheter<br>* Placement of a tunneled cuffed catheter in surgical theatre<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite primary end-point of any access related complication | Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis | From placement of vascular access through study completion, an average of 3 years. |