Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas

Hemodialysis Access Failure Clinical Trial

Official title:

Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Upper Extremity Arteriovenous Fistulas: A Pilot Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04376567
• Other study ID #: 0702
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.

Description:

The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years;

2. ESRD receiving hemodialysis in need for new hemodialysis access;

3. Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;

4. Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;

5. Life expectancy = 12 months;

Exclusion Criteria:

1. Life expectancy < 12 months;

2. Brachial artery stenosis or occlusion;

3. A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);

4. Current immunosuppressive medication, chemotherapy or radiation therapy;

5. Pregnancy or lactation

Related Conditions & MeSH terms

• Arterio-venous Fistula
• Arteriovenous Fistula
• End Stage Renal Failure
• Fistula
• Hemodialysis Access Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• One stage approach
Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.

Locations

Country	Name	City	State
United States	Banner University Medical Center Tucson	Tucson	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
Tze-Woei Tan	Boston University, Rancho Los Amigos National Rehabilitation Center, University of Southern California, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of participants who had successful use of arteriovenous fistula for dialysis	Functional clinical patency: Numbers of participant who had successful use of brachial basilic arteriovenous fistula (BBAVF) in 75% of dialysis sessions over four weeks without need for additional procedure or surgery.	6 months
Secondary	Numbers of participants who had catheter related complications	Numbers of participants with dialysis catheter related complications, including infection, procedure to exchange catheter due to malfunction.; outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death	12 months
Secondary	Duration of catheter dependency for dialysis after arteriovenous fistula creation in day	Average duration of catheter dependency after BBAVF creation in participants who required dialysis	12 months
Secondary	Patient reported quality of life	Average ratings of quality of life among participants using the Patient-Reported Outcomes Measurement Information System in physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships.	6-month and 12-month