AUSTrian Randomized Interventional Study on Dialysis Accesses

NCT03764358 | Unknown

• 1 other identifier: AUSTRIA
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Catheter Infection; Shunt Malfunction

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Arteriovenous fistula

ACTIVE COMPARATOR

Device: Arteriovenous Fistula

Tunneled Cuffed Catheter

EXPERIMENTAL

Device: Tunneled Cuffed Catheter

Interventions

Arteriovenous Fistula DEVICE

Surgical implantation of an arteriovenous fistula for hemodialysis

Arteriovenous fistula

Tunneled Cuffed Catheter DEVICE

Placement of a tunneled cuffed catheter in surgical theatre

Tunneled Cuffed Catheter

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Medicine III, Devision of Nephrology and Dialysis, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Arteriovenous Shunt, Surgical

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Guerkan Sengoelge, MD

  Medical University of Vienna, Department of Medicine III, Devision of Nephrology and Dialysis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Schairer, MD

CONTACT

0043 40400 43890; benjamin.schairer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: March 6, 2019
• Primary Completion: April 4, 2022
• Study Completion: October 4, 2022
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

AU (1)