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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arteriovenous fistula | Active Comparator |
| |
| Tunneled Cuffed Catheter | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arteriovenous Fistula | Device | Surgical implantation of an arteriovenous fistula for hemodialysis |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Schairer, MD | Contact | 0043 40400 43890 | benjamin.schairer@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Guerkan Sengoelge, MD | Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D001166 | Arteriovenous Shunt, Surgical |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
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| Tunneled Cuffed Catheter | Device | Placement of a tunneled cuffed catheter in surgical theatre |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013504 | Cardiovascular Surgical Procedures |