103 Participants Needed

AV Graft vs. Surgical Fistula for Kidney Failure

Recruiting at 9 trial locations
MR
BB
BB
Overseen ByBrindusa Burciu
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment AV Graft, Arteriovenous Graft, AV Graft, Vascular Graft, Surgical Intervention for Creation of a Fistula, Arteriovenous Fistula Creation, AV Fistula Surgery, Surgical Intervention for Creation of a Fistula for kidney failure?

Recent studies suggest that in older adults with end-stage kidney disease, arteriovenous grafts (AVGs) might be a better option than arteriovenous fistulas (AVFs) for hemodialysis, although more evidence is needed to confirm this. AVFs have traditionally been preferred, but AVGs may offer advantages in certain patient groups.12345

Is the surgical creation of an arteriovenous fistula or graft generally safe for humans?

The surgical creation of an arteriovenous fistula (AVF) or graft (AVG) is generally considered safe, but it can have complications such as bleeding and thrombosis (blood clots). There is also a risk of heart failure or hand ischemia (reduced blood flow) due to high blood flow in the fistula.16789

How does the AV Graft or Surgical Fistula treatment for kidney failure differ from other treatments?

The AV Graft and Surgical Fistula treatments are unique because they provide a long-term solution for vascular access in hemodialysis, which is crucial for patients with end-stage kidney disease. While AV Fistulas are traditionally preferred for their durability, recent studies suggest that AV Grafts might be a better option for older adults, offering a potentially more suitable alternative depending on the patient's age and condition.13101112

What is the purpose of this trial?

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

Research Team

MA

Michael Allon, MD

Principal Investigator

University of Alabama at Birmingham

MM

Mariana Murea, MD

Principal Investigator

Wake Forest Health Sciences

MP

Matthew P Goldman, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

You currently rely only on a central venous catheter for hemodialysis.
I am 60 years old or older.
I am on long-term hemodialysis for kidney failure.
See 6 more

Exclusion Criteria

I expect to start peritoneal dialysis within the next year.
I am scheduled for a procedure to create a connection between an artery and vein using methods other than stitches or clips.
I have severe heart issues, including very low heart pump function, a heart transplant, or a device to help my heart pump.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical placement of either a fistula or graft for permanent hemodialysis access

Up to 4 years
Regular visits for dialysis and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction with vascular access

4 years
Visits at baseline, Months 1, 6, 12, and annually

Outcome Assessment

Assessment of catheter-free dialysis days, infections, and patient-reported outcomes

Up to 4 years

Treatment Details

Interventions

  • AV Graft
  • Surgical Intervention for Creation of a Fistula
Trial Overview The study compares two surgical methods for creating arteriovenous access in patients: an AV graft versus a fistula. It aims to determine which is more effective and safer for older adults with multiple chronic conditions who are undergoing long-term hemodialysis treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: fistula surgically placedExperimental Treatment1 Intervention
Randomized group to have surgically placed fistula for permanent hemodialysis access
Group II: graft surgically placedActive Control1 Intervention
Randomized group to have surgically placed graft for permanent hemodialysis access

AV Graft is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Arteriovenous Graft for:
  • End-stage renal disease (ESRD)
  • Hemodialysis access
🇪🇺
Approved in European Union as AV Graft for:
  • 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

Trials
1,432
Recruited
2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

In a pilot study involving 36 older adults with end-stage kidney disease, both arteriovenous fistulas (AVF) and arteriovenous grafts (AVG) showed a primary access failure rate of 31%, indicating similar initial outcomes for both types of vascular access.
Successful cannulation rates were slightly higher for AVG (62%) compared to AVF (50%), but the differences were not substantial enough to favor one method over the other, suggesting that further research with larger sample sizes is needed to determine the best option for this population.
Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial.Robinson, T., Geary, RL., Davis, RP., et al.[2022]
In a study of 136 surgical salvage procedures for arteriovenous fistulas (AVFs), the cumulative patency rates were high at 91% at 3 months, 83% at 6 months, and 77% at 12 months, indicating effective long-term outcomes.
The most common salvage procedures included re-anastomosis (37.2%) and AVF declotting (34.1%), highlighting the effectiveness of these techniques in managing complicated AVFs.
[Salvage of vascular access: a case study from the Columbus nephrology division, Rome, Italy].Ferraro, PM., Lombardi, G., D'Ascenzo, F., et al.[2013]
The AV Access Study is a prospective, multicenter, randomized controlled trial involving 262 older adults (≥60 years) with chronic hemodialysis to compare the clinical outcomes of arteriovenous fistulas (AVFs) versus arteriovenous grafts (AVGs) over an average follow-up of 2 years.
The primary outcome will measure the rate of central venous catheter (CVC)-free days, while the primary safety outcome will assess severe infections related to vascular access, aiming to provide robust evidence for optimizing vascular access care in this patient population.
Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial.Murea, M., Gardezi, AI., Goldman, MP., et al.[2023]

References

Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. [2022]
[Salvage of vascular access: a case study from the Columbus nephrology division, Rome, Italy]. [2013]
Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial. [2023]
Survival of arteriovenous fistula for dialysis at different centers in the North of England. [2019]
Association Between Type of Vascular Access Used in Hemodialysis Patients and Subsequent Kidney Transplant Outcomes. [2023]
A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. [2020]
Arteriovenous fistulas after ultrasound-guided needle biopsy of kidney allografts and treatment outcomes after transcatheter embolization: A single-center experience in Japan. [2021]
A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis. [2018]
Computational model for prediction of fistula outcome. [2017]
Brief overview of surgical aspect of autologous arterio-venous fistula for dialysis access. [2021]
Early versus late arterio-venous fistulae: impact on failure rate. [2012]
12.United Statespubmed.ncbi.nlm.nih.gov
Unraveling the realities of vascular access: the Network 11 experience. [2019]
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