Comparing arteriovenous access methods for older adults with kidney disease
A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis
This study is testing which method of creating access for dialysis—either a fistula or a graft—works better and is safer for older adults with kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 7 sites (Birmingham, Alabama and 6 other locations) |
| Trial ID | NCT04646226 on ClinicalTrials.gov |
What this trial studies
This study aims to prospectively compare the effectiveness and safety of arteriovenous fistula versus arteriovenous graft placement in older adults suffering from end-stage kidney disease and multiple chronic conditions. It will evaluate the impact of these access methods on the rate of catheter-free dialysis days, access-related infections, associated costs, and patient satisfaction with the vascular access care process. Additionally, the study will explore the relationship between preoperative functional status and the incidence of maturation failure for both access types.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 and older with end-stage kidney disease currently using a central venous catheter for hemodialysis and having at least one comorbid condition.
Not a fit: Patients with severe cardiac disease may not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved vascular access strategies that enhance patient outcomes and satisfaction in hemodialysis.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific comparison of access methods in older adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 6 other locations
- University of Alabama at Birmingham School of Medicine — Birmingham, Alabama, United States (Recruiting)
- UCLA — Los Angeles, California, United States (Recruiting)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Terminated)
- Atrium Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- Prisma Health Upstate — Greenville, South Carolina, United States (Recruiting)
- University of Tennessee Medical Center at Knoxville — Knoxville, Tennessee, United States (Recruiting)
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Mariana Murea, MD — Wake Forest Health Sciences
- Study coordinator: Brindusa Burciu
- Email: bburciu@wakehealth.edu
- Phone: 336-716-8671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.