AUSTrian Randomized Interventional Study on Dialysis Accesses (AUSTRIA)

Medical University of Vienna

Status: Unknown

Conditions: End Stage Renal Disease; Shunt Malfunction; Catheter Infection

Treatments: Device: Arteriovenous Fistula; Device: Tunneled Cuffed Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03764358

AUSTRIA

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Arteriovenous fistula

Active Comparator group

Treatment:

Device: Arteriovenous Fistula

Tunneled Cuffed Catheter

Experimental group

Treatment:

Device: Tunneled Cuffed Catheter