Catheter Infection, End Stage Renal Disease, Shunt Malfunction
Conditions
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.
Interventions
DEVICEArteriovenous Fistula
Surgical implantation of an arteriovenous fistula for hemodialysis
DEVICETunneled Cuffed Catheter
Placement of a tunneled cuffed catheter in surgical theatre
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite primary end-point of any access related complication | From placement of vascular access through study completion, an average of 3 years. | Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis |
Countries
Austria
Contacts
Primary ContactBenjamin Schairer, MD
Outcome results
None listed