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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
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)
The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States
UCLA
Los Angeles, California, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Atrium Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
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
Time frame: 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
Time frame: Until death, collected up to 4 years
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
Time frame: 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
Time frame: 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)
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Prisma Health Upstate
Greenville, South Carolina, United States
University of Tennessee Medical Center at Knoxville
Knoxville, Tennessee, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: Until death, collected up to 4 years