AV Graft vs. Surgical Fistula for Kidney Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to compare two surgical options for creating a reliable access point for dialysis in people with severe kidney failure. It will evaluate the effectiveness and safety of each method: one uses a natural blood vessel (fistula), and the other uses a synthetic tube (known as an AV Graft). The trial seeks participants who are on dialysis through a central line, have been recommended for surgery by their kidney doctor, and have conditions like heart disease or diabetes. As an unphased trial, this study offers participants the chance to contribute to important research that may improve future dialysis treatments.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these arteriovenous access placements are safe for older adults with end stage kidney disease?
Research has shown that both arteriovenous grafts (AVGs) and surgeries to create a fistula present safety concerns for people with kidney failure. Studies suggest that older patients using AV grafts might face a higher risk of health issues, including lower survival rates and more frequent problems with the graft itself.
Conversely, creating a fistula through surgery is often safer in some respects. Research indicates that fistula surgeries usually result in fewer complications. These procedures tend to cause fewer immediate post-surgery problems and often lead to better long-term outcomes. However, both options involve surgery, which always carries some risk.
In summary, while both treatments are widely used and researched, AV grafts may pose a higher risk of complications compared to fistulas. It is crucial for individuals to consult with a healthcare provider to determine the best option for their specific situation.12345Why are researchers excited about this trial?
Researchers are excited about the trial comparing AV grafts and surgical fistulas for kidney failure because it aims to pinpoint which method offers better long-term results for patients needing hemodialysis. Unlike current options, this trial directly compares the durability and effectiveness of AV grafts, known for quicker usability post-surgery, against surgical fistulas, which are often preferred for their longer-lasting functionality. The study could provide crucial insights into optimizing dialysis access, potentially improving patient outcomes and quality of life for those with kidney failure.
What evidence suggests that this trial's treatments could be effective for end stage kidney disease?
This trial will compare the effectiveness of two surgical options for permanent hemodialysis access: arteriovenous grafts and surgically placed fistulas. Studies have shown that older patients face a 50-65% higher risk of initial failure with arteriovenous fistulas and an 80% higher risk of complications later compared to grafts. These findings come from a meta-analysis, which combines results from several studies. Conversely, research indicates that fistulas become fully functional 67% of the time at 6 months and 76% of the time at 12 months. Both options—grafts and fistulas—have their pros and cons, and their effectiveness can vary based on individual patient conditions. It is important to consider both options and discuss them with a healthcare provider.16789
Who Is on the Research Team?
Mariana Murea, MD
Principal Investigator
Wake Forest Health Sciences
Matthew P Goldman, MD
Principal Investigator
Wake Forest University Health Sciences
Michael Allon, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for older adults aged 60 or above with end-stage kidney disease on hemodialysis, specifically those using a central venous catheter and having cardiovascular disease, peripheral vascular disease, or diabetes. Candidates must be deemed suitable for AV access surgery by their surgeon and referred by a nephrologist. Exclusions include severe cardiac conditions, anticipated kidney transplant within the year, or plans to switch to peritoneal dialysis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical placement of either a fistula or graft for permanent hemodialysis access
Follow-up
Participants are monitored for safety, effectiveness, and satisfaction with vascular access
Outcome Assessment
Assessment of catheter-free dialysis days, infections, and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- AV Graft
- Surgical Intervention for Creation of a Fistula
AV Graft is already approved in United States, European Union for the following indications:
- End-stage renal disease (ESRD)
- Hemodialysis access
- Chronic kidney disease
- Renal failure requiring dialysis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Institute on Aging (NIA)
Collaborator