NCT03764358

AUSTrian Randomized Interventional Study on Dialysis Accesses

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• End Stage Renal Disease
• Catheter Infection
• Shunt Malfunction

Interventions

Type	Name	Description
DEVICE	Arteriovenous Fistula	Surgical implantation of an arteriovenous fistula for hemodialysis
DEVICE	Tunneled Cuffed Catheter	Placement of a tunneled cuffed catheter in surgical theatre

Timeline

• Start date: 2019-03-06
• Primary completion: 2022-04-04
• Completion: 2022-10-04
• First posted: 2018-12-05
• Last updated: 2018-12-05

Locations

1 site across 1 country: Austria