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AUSTrian Randomized Interventional Study on Dialysis Accesses

NCT03764358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-12-05

No results posted yet for this study

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

Interventions

DEVICE

Arteriovenous Fistula

Surgical implantation of an arteriovenous fistula for hemodialysis

DEVICE

Tunneled Cuffed Catheter

Placement of a tunneled cuffed catheter in surgical theatre

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Guerkan Sengoelge, MD · Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2022-04-04
Completion
2022-10-04

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764358 on ClinicalTrials.gov