Clinical trial NCT04376567: Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas
Official title: Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Upper Extremity Arteriovenous Fistulas: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End Stage Renal Failure
Hemodialysis Access Failure
Arterio-venous Fistula
Keywords: Renal failure
Upper extremity arteriovenous fistula
Brachial basilic arteriovenous fistula
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Boston University
name: University of Southern California
name: Rancho Los Amigos National Rehabilitation Center
First posted: 2020-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assigned to either a one-stage or two-stage approach for brachial-basilic arteriovenous fistula (BBAVF) creation in a 1:1 ratio.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Numbers of participants who had successful use of arteriovenous fistula for dialysis
timeFrame: 6 months
Secondary outcomes:
measure: Numbers of participants who had catheter related complications
timeFrame: 12 months
measure: Duration of catheter dependency for dialysis after arteriovenous fistula creation in day
timeFrame: 12 months
measure: Patient reported quality of life
timeFrame: 6-month and 12-month
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center Tucson
state: Arizona
Study officials:
affiliation: Banner University Medical Center Tucson/University of Arizona
name: Tze-Woei Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: