AUSTrian Randomized Interventional Study on Dialysis Accesses

End Stage Renal Disease Clinical Trial

— AUSTRIA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03764358
• Other study ID #: AUSTRIA
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: October 4, 2022

Study information

• Verified date: December 2018
• Source: Medical University of Vienna
• Contact: Benjamin Schairer, MD
• Phone: 0043 40400 43890
• Email: benjamin.schairer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: October 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Infection
• End Stage Renal Disease
• Kidney Failure, Chronic
• Shunt Malfunction

Intervention

Device:
• Arteriovenous Fistula
Surgical implantation of an arteriovenous fistula for hemodialysis
• Tunneled Cuffed Catheter
Placement of a tunneled cuffed catheter in surgical theatre

Locations

Country	Name	City	State
Austria	Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.