AUSTrian Randomized Interventional Study on Dialysis Accesses (AUSTRIA)

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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Disease; Catheter Infection; Shunt Malfunction
• Intervention / Treatment: Device: Arteriovenous Fistula; Device: Tunneled Cuffed Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin Schairer, MD; Phone Number: 0043 40400 43890; Email: benjamin.schairer@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna
    • Contact: Benjamin Schairer, MD; Phone Number: 43890 0043 40400; Email: benjamin.schairer@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Guerkan Sengoelge, MD, Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis

Study record dates

Study Major Dates

• Study Start (Anticipated): March 6, 2019
• Primary Completion (Anticipated): April 4, 2022
• Study Completion (Anticipated): October 4, 2022

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: AUSTRIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No