The Arteriovenous Vascular (AV) ACCESS Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis

Conditions
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End-Stage Kidney Disease, Hemodialysis Complication

Intervention / Treatment
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* Device: AV graft
* Procedure: surgical intervention for creation of a fistula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 years or older End-stage kidney disease on hemodialysis via a central venous catheter Hemodialysis is the long-term modality of treatment for end-stage kidney disease Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation Referred by patient's nephrologist for placement of arteriovenous access At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon Patient agreed to study participation and signed the informed consent Exclusion Criteria: Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices) Anticipated kidney transplant within 12 months Anticipated conversion to peritoneal dialysis within 12 months Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months Anticipated non-compliance with medical care based on physician judgment A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fistula surgically placed<br>Randomized group to have surgically placed fistula for permanent hemodialysis access | Procedure: surgical intervention for creation of a fistula<br>* The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)<br>|
| Active Comparator: graft surgically placed<br>Randomized group to have surgically placed graft for permanent hemodialysis access | Device: AV graft<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, End-Stage Kidney Disease, central venous catheters, arteriovenous fistula [AVF], arteriovenous graft [AVG], Arteriovenous Vascular Access