The Arteriovenous Vascular (AV) ACCESS Trial
a study on End Stage Renal Disease Kidney Disease Dialysis Fistula Chronic Kidney Disease
Summary
- Eligibility
- for people ages 60 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedcompletion around
Description
Summary
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
Official Title
A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis
Details
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
Keywords
End-Stage Kidney Disease, Hemodialysis Complication, Hemodialysis, central venous catheters, arteriovenous fistula [AVF], arteriovenous graft [AVG], Arteriovenous Vascular Access, Kidney Diseases, Chronic Kidney Failure, AV graft, surgical intervention for creation of a fistula, fistula surgically placed, graft surgically placed
Eligibility
You can join if…
Open to people ages 60 years and up
- 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
You CAN'T join if...
- 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.
Locations
- UCLA
accepting new patients
Los Angeles California 90095 United States - University of Wisconsin School of Medicine and Public Health
accepting new patients
Madison Wisconsin 53726 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Wake Forest University Health Sciences
- ID
- NCT04646226
- Study Type
- Interventional
- Participants
- Expecting 103 study participants
- Last Updated