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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG071803-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions
This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fistula surgically placed | Experimental | Randomized group to have surgically placed fistula for permanent hemodialysis access |
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| graft surgically placed | Active Comparator | Randomized group to have surgically placed graft for permanent hemodialysis access |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV graft | Device | The purpose of the surgery is to connect a large vein in the arm to a nearby artery indirectly by inserting a graft material (graft surgery) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Catheter-free dialysis days | Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days | Until death, collected up to 4 years |
| Number of Infections | Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment | Until death, collected up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular access-related cost per patient-year | The total cost will represent the sum of costs for adjuvant procedures (endovascular and surgical) related to fistula or graft access; central venous catheter (CVC) - related interventions; infectious complications related to fistula or graft access; infectious complications related to CVC; and hospitalizations related to fistula or graft access and/or CVC. All access-related costs will be expressed as mean cost (in U.S. dollars) per patient per year |
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Access Score | Satisfaction with different processes of vascular access care (catheter, fistula, or graft) - vascular access questionnaire (VAQ) - satisfaction with the vascular access using the vascular access questionnaire - patient-reported questionnaire composed of 17 vascular access related questions with responses on a five-point Likert scale which are summed, to give a Vascular Access Score- Score range is 4 to 20, with lower scores indicating more satisfaction with the vascular access |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana Murea, MD | Wake Forest Health Sciences | Principal Investigator |
| Matthew P Goldman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Michael Allon, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine | Birmingham | Alabama | 35487 | United States | ||
| UCLA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36829135 | Derived | Murea M, Gardezi AI, Goldman MP, Hicks CW, Lee T, Middleton JP, Shingarev R, Vachharajani TJ, Woo K, Abdelnour LM, Bennett KM, Geetha D, Kirksey L, Southerland KW, Young CJ, Brown WM, Bahnson J, Chen H, Allon M. Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial. BMC Nephrol. 2023 Feb 24;24(1):43. doi: 10.1186/s12882-023-03086-5. |
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Available upon investigator request
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Study will determine if placement of a graft access will be more effective at having access switched from catheter to using the graft; have fewer interventions on the graft access; have better arm function; have better self-sufficiency with daily activities; and better quality of life compared to those who receive a fistula - identify strategies that decrease dialysis access failure and improve quality of life
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| surgical intervention for creation of a fistula | Procedure | The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery) |
|
| Year 2 |
| Incidence rate of study fistula/graft primary maturation failure | Study fistula or graft primary maturation failure is defined as permanent failure of the fistula or graft before hemodialysis suitability, and the study fistula or graft access was abandoned. Causes of fistula or graft primary maturation failure include inadequate vasculature, thrombosis, inability to achieve successful cannulation, and other complications leading to nonfunctional fistula or graft - Abandonment of the study fistula or graft access is defined as the point at which the fistula or graft access cannot be cannulated and no further attempts will be made to rescue or revise the access | hour 72, Month 3, Month 6, and Year 4 |
| Time to successful fistula/graft access cannulation | This is the time from the date of surgical creation of study AV access (fistula or graft) to the date of successful access cannulation. The date of successful access cannulation is defined as the date when the study fistula or graft access became the primary vascular access for hemodialysis (i.e., the fistula or graft access became the sole vascular access for hemodialysis and the CVC was removed) | Until death, collected up to 4 years |
| Incidence rate of fistula/graft access hemodialysis suitability | Study AV access use (fistula or graft) with two needles for at least 8 out of 12 hemodialysis sessions occurring during the 30-day suitability ascertainment period | Month 6 |
| Functional patency of study fistula or graft access | Total duration of successful use of the study fistula or graft access (i.e., the study fistula or graft access was the sole means of hemodialysis vascular access) | Until death, collected up to 4 years |
| Rate of adjuvant endovascular and surgical procedures | All endovascular and surgical procedures performed to evaluate the study fistula or graft access, or to aid or maintain study fistula or graft access functional patency will be included in this outcome. Adjuvant endovascular interventions include: percutaneous thrombectomy; percutaneous revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; and dilation of central venous stenosis. Adjuvant surgical interventions include: surgical thrombectomy; dilation of central venous stenosis; surgical revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; ligation of tributaries; superficialization of study fistula; second-stage planned procedure for brachio-basilic fistula creation; ligation of fistula or salvage by distal reconstruction and interval ligation due to distal ischemia. | Until death, collected up to 4 years |
| baseline and Months 6 and 12 |
| SUPPORT Trial questionnaire | Will be based on the SUPPORT Trial questionnaire which has two items. The first question asks patients to choose their top priority, extension of life or relieving discomfort as much as possible. The second question asks patients to use the same categories to describe the focus of AV access care they received - This questionnaire will be analyzed using qualitative methods | baseline and Months 6, and 12 |
| Decision Regret Scale | Measuring the regret of AV access placement will be assessed using the Decision Regret Scale - The Decision Regret Scale is a 5-item Likert-type measure written to assess regret or remorse following a medical decision. Patients respond to the items after reading the prompt: "Please think about the decision you made about [chosen health care decision] after talking to your [doctor, surgeon, nurse, health professional, etc.]." High scores suggest high regret over a health care decision. Scores may be transformed to a scale of 0 (no regret) to 100 (high regret) | Months 6, and 12 |
| Attitude Scale | Participant's preferences between quantity and quality of life and future/present health using the Attitude Scale - An attitude scale is designed to provide a valid, or accurate, measure of an individual's social attitude - The Attitude Scale is composed of 9 items in which participants are asked to rate the strength of the statements, each representing a tradeoff between quality and quantity of life; total score range 9 to 45, with higher scores denoting that quality of life/current health is more important than quantity of life/future health | Months 6, and 12 |
| Grip strength | Assessed with upper arm grip-strength test in each arm using a hand-held dynamometer - A dynamometer provides objective grip strength data. Males normally can generate about 46 kg of force, and females about 23 kg - A cut-off point <16 kg in women and <26 kg in men will define muscle weakness | Months 1, 6, and 12 |
| Chair stand test | The chair stand testing will be a timed repetition of rising from a chair and sitting down five times. The test will be scored based on the time (seconds) it takes to complete the five consecutive stand-up-sit-down workouts - longer times denotes worse outcomes. The score ranges from 0 to 4 based on pre-established time cut-offs: 4 points if ≤11.19 sec, 3 points if 11.20-13.69 sec, 2 points if 13.70-16.69 sec, 1 point if ≥16.70 sec, and 0 points if >60 sec or unable. | Months 1, 6, and 12 |
| Clinical Frailty Scale | Participant's level of frailty using the Clinical Frailty Scale - The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill) -The scale will be graded from 1 to 7 (1, severely frail; 2, moderately frail; 3, mildly frail; 4, apparently vulnerable; 5, well with treated comorbid disease; 6, well without active disease; 7, very fit | Months 1, 6, and 12 |
| Pepper Assessment Tool for Disability (PAT-D) | Self-report disability questionnaire using the Pepper Assessment Tool for Disability - The PAT-D self-administered questionnaire consists of 23 items that include a range of activities that assess mobility, activities of daily living (ADL) and instrumental activities of daily living (IADL). For each item, respondents answer whether they experience (1) unable to do, (2) a lot of difficulty, (3) some difficulty, (4) a little difficulty, (5) no difficulty. The summary score, a mean of the three domain scores that ranges from 1 to 5, is an indication of a person's overall perceived disability. | Months 1, 6, and 12 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21205 | United States |
| Atrium Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Prisma Health Upstate | Greenville | South Carolina | 29601 | United States |
| University of Tennessee Medical Center at Knoxville | Knoxville | Tennessee | 37920 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53726 | United States |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |