End Stage Renal Failure Clinical Trial
Official title:
Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas: A Pilot Trial
NCT number | NCT04376567 |
Other study ID # | 0702 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | May 15, 2023 |
The absence of reliable data to establish the optimal surgical approach for creating a new Brachial Basilic Arteriovenous Fistula (BBAVF) has resulted in high degree of treatment equipoise and the decision to use one-stage or two-stage approach is largely based on surgeon's preference. The pilot trial will provide a framework for an evidence-based surgical approach to create a BBAVF for patients receiving renal replacement therapy. The pragmatic trial design will allow the inclusion of different surgical techniques currently used by the access surgeons to create a new BBAVF. Subjects in whom randomly assigned approach (one-stage or two-stage) is not completed will be considered appropriately treated as intended to account for the risk of primary fistula failure. The investigator will use the patient-centric clinical endpoints and patient reported outcomes (PROs) to incorporate the perspective of patients undergoing complex The goal is to prospectively evaluate the impact of the one-stage and two-stage BBAVF approaches on qualitative quality of life (QOL) in order to address the knowledge gap within the existing literature on complex arterovenous fistula (AVF) procedures. The investigator will use the NIH-sponsored Patient-Reported Outcome Measurement Information System (PROMIS) Computerized Adaptive Testing (CAT) tool to evaluate self-reported measures for functions, symptoms, behaviors, and feelings following the BBAVF procedure
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 15, 2023 |
Est. primary completion date | August 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age = 18 years; 2. ESRD receiving hemodialysis (CVC) 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; 6. Anticipated ability to comply with study procedures 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 - |
Country | Name | City | State |
---|---|---|---|
United States | Banner University Medical Center Tucson | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Tze-Woei Tan | Boston University, University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Functional Patency | successful use of the index BBAVF with two needles for >75% of dialysis sessions over a continuous 4-week period without any endovascular or surgical procedure on the fistula. Time to first occurrence of a qualifying clinical event will be compared utilizing follow-up at 6-month and 12-month after fistula creation | 4 weeks | |
Secondary | Fistula related outcomes | physical outcomes outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death | one year | |
Secondary | patient reported outcomes | patient reported outcomes using PROMIS CAT testing | compared over 1 year |
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