The Arteriovenous Vascular (AV) ACCESS Trial

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Nov 20, 2020

Keywords

ClinConnect Summary

The AV ACCESS Trial is a clinical study that aims to compare two methods of creating vascular access for hemodialysis in older adults with end-stage kidney disease. Specifically, it looks at the effectiveness and safety of an arteriovenous fistula (a connection made between an artery and a vein) versus an arteriovenous graft (a tube used to connect an artery to a vein) in patients who are 60 years or older and have other health issues, such as heart disease or diabetes. This trial is currently recruiting participants who are using a central venous catheter for their hemodialysis.

To be eligible for this study, participants must be at least 60 years old, have end-stage kidney disease requiring hemodialysis, and be referred by their kidney doctor for vascular access creation. They should also have suitable blood vessels for the procedure, as determined by their surgeon. If you decide to participate, you will undergo a surgical procedure to create the access needed for your hemodialysis treatment, and throughout the trial, your health will be monitored to see how well the different methods work. This study is an important step in understanding the best options for patients needing hemodialysis and could help improve treatment for others in the future.

Gender

ALL

Eligibility criteria

• 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.