Arterio-venous Fistula, End Stage Renal Failure, Hemodialysis Access Failure
Conditions
Keywords
Renal failure, Upper extremity arteriovenous fistula, Brachial basilic arteriovenous fistula
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.
Interventions
PROCEDUREOne stage approach
Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.
Sponsors
University of Utah
Rancho Los Amigos National Rehabilitation Center
Tze-Woei Tan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis | 6 months | Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Catheter Related Complications | 6 months | Number 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 |
| Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation | 6 months | Number of participants who had \> 3 months of catheter dependency after arteriovenous fistula creation |
| Patient-Reported Outcomes Measurement Information System Scores Over 6 Months | 6-month | Average quality of life scores assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical function, fatigue, sleep disturbance, and ability to participate in social roles and activities. Data are presented as T-score, which are standardized scores with a mean of 50 and a standard deviation for the reference population (typically the US general population). A T-score of 50 represents the population average. A higher T-score indicates more of the concept being measured and lower T-score indicate less. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| One Stage Approach To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure.
One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. | 1 |
| Two Stage Approach To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured.
One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Total | One Stage Approach | Two Stage Approach |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 1 Participants |
| Dialysis | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis
Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One Stage Approach | Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis | 1 Participants |
| Two Stage Approach | Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis | 1 Participants |
Secondary
Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation
Number of participants who had \> 3 months of catheter dependency after arteriovenous fistula creation
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One Stage Approach | Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation | 0 Participants |
| Two Stage Approach | Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation | 0 Participants |
Secondary
Number of Participants Who Had Catheter Related Complications
Number 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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| One Stage Approach | Number of Participants Who Had Catheter Related Complications | 1 Participants |
| Two Stage Approach | Number of Participants Who Had Catheter Related Complications | 1 Participants |
Secondary
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months
Average quality of life scores assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical function, fatigue, sleep disturbance, and ability to participate in social roles and activities. Data are presented as T-score, which are standardized scores with a mean of 50 and a standard deviation for the reference population (typically the US general population). A T-score of 50 represents the population average. A higher T-score indicates more of the concept being measured and lower T-score indicate less.
Time frame: 6-month
Population: Participate did not complete PROMIS questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Stage Approach | Patient-Reported Outcomes Measurement Information System Scores Over 6 Months | Physical function (T-score) | 37.5 score on a scale | Standard Deviation 33.2 |
| One Stage Approach | Patient-Reported Outcomes Measurement Information System Scores Over 6 Months | Fatigue (T-score) | 52.3 score on a scale | Standard Deviation 61.6 |
| One Stage Approach | Patient-Reported Outcomes Measurement Information System Scores Over 6 Months | Sleep disturbance (T-score) | 53.6 score on a scale | Standard Deviation 39.6 |
| One Stage Approach | Patient-Reported Outcomes Measurement Information System Scores Over 6 Months | Ability to participate in social roles and activities (T-score) | 44.7 score on a scale | Standard Deviation 23.7 |