An interventional study of Arteriovenous Fistula and Tunneled Cuffed Catheter in End Stage Renal Disease, Catheter Infection and Shunt Malfunction, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Prevention
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 220 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
Device: Arteriovenous Fistula
Device: Tunneled Cuffed Catheter
Surgical implantation of an arteriovenous fistula for hemodialysis
Placement of a tunneled cuffed catheter in surgical theatre
Composite primary end-point of any access related complication
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.
Plan to share: Undecided
No publications or documents are linked to this record.
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Medical University of Vienna