AUSTrian Randomized Interventional Study on Dialysis Accesses (AUSTRIA)
Primary Purpose
End Stage Renal Disease, Catheter Infection, Shunt Malfunction
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Arteriovenous Fistula
Tunneled Cuffed Catheter
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease
Eligibility Criteria
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.
Sites / Locations
- Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arteriovenous fistula
Tunneled Cuffed Catheter
Arm Description
Outcomes
Primary Outcome Measures
Composite primary end-point of any access related complication
Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis
Secondary Outcome Measures
Full Information
NCT ID
NCT03764358
First Posted
December 3, 2018
Last Updated
December 3, 2018
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03764358
Brief Title
AUSTrian Randomized Interventional Study on Dialysis Accesses
Acronym
AUSTRIA
Official Title
Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2019 (Anticipated)
Primary Completion Date
April 4, 2022 (Anticipated)
Study Completion Date
October 4, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Catheter Infection, Shunt Malfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arteriovenous fistula
Arm Type
Active Comparator
Arm Title
Tunneled Cuffed Catheter
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Arteriovenous Fistula
Intervention Description
Surgical implantation of an arteriovenous fistula for hemodialysis
Intervention Type
Device
Intervention Name(s)
Tunneled Cuffed Catheter
Intervention Description
Placement of a tunneled cuffed catheter in surgical theatre
Primary Outcome Measure Information:
Title
Composite primary end-point of any access related complication
Description
Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis
Time Frame
From placement of vascular access through study completion, an average of 3 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Schairer, MD
Phone
0043 40400 43890
Email
benjamin.schairer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guerkan Sengoelge, MD
Organizational Affiliation
Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Schairer, MD
Phone
0043 40400
Ext
43890
Email
benjamin.schairer@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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AUSTrian Randomized Interventional Study on Dialysis Accesses
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