NCT03764358: AUSTRIA

AUSTrian Randomized Interventional Study on Dialysis Accesses

Status unknown NA Last updated 5 December 2018

What this trial tests

NA trial testing Arteriovenous Fistula in End Stage Renal Disease in 220 participants. Status unknown.

Timeline

6 March 2019

Primary endpoint
4 April 2022

4 October 2022

Quick facts

Lead sponsor	Medical University of Vienna
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	220
Start date	6 March 2019
Primary completion	4 April 2022
Estimated completion	4 October 2022
Sites	1 location across Austria

Drugs / interventions tested

• Arteriovenous Fistula
• Tunneled Cuffed Catheter

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →
• Catheter Infection — all drugs for Catheter Infection →
• Shunt Malfunction — all drugs for Shunt Malfunction →

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 99, any sex, with End Stage Renal Disease or Catheter Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.