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Vascular Access

AV Graft vs. Surgical Fistula for Kidney Failure

N/A
Recruiting
Led By Michael Allon
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 60 years or older
Hemodialysis is the long-term modality of treatment for end-stage kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death, collected up to 4 years
Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of two types of arteriovenous access placement for people with end stage kidney disease and multiple chronic conditions.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from the interventions may include complications at the surgical site such as infection, clotting of the new access point (fistula or graft), bleeding issues, possible heart strain due to increased blood flow through the new access point, and arm swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I am on long-term hemodialysis for kidney failure.
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I have a heart condition, blood vessel disease, or diabetes.
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I am on hemodialysis for end-stage kidney disease using a central line.
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My doctor has approved me for surgery to create a blood vessel connection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death, collected up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death, collected up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Catheter-free dialysis days
Number of Infections
Secondary outcome measures
Functional patency of study fistula or graft access
Incidence rate of fistula/graft access hemodialysis suitability
Incidence rate of study fistula/graft primary maturation failure
+3 more
Other outcome measures
Attitude Scale
Chair stand test
Clinical Frailty Scale
+5 more

Trial Design

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

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,960 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,134 Total Patients Enrolled
2 Trials studying Kidney Failure
5,030 Patients Enrolled for Kidney Failure
Michael AllonPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

AV Graft (Vascular Access) Clinical Trial Eligibility Overview. Trial Name: NCT04646226 — N/A
Kidney Failure Research Study Groups: fistula surgically placed, graft surgically placed
Kidney Failure Clinical Trial 2023: AV Graft Highlights & Side Effects. Trial Name: NCT04646226 — N/A
AV Graft (Vascular Access) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646226 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is this medical study attempting to accomplish?

"The primary aim of this clinical trial, which will last up to 4 years or until death, is to gauge the Number of Infections. Secondary outcomes include Time to successful fistula/graft access cannulation (defined as period between surgical creation and sole use for hemodialysis), Rate of adjuvant endovascular and surgical procedures (such as percutaneous thrombectomy, angioplasty with stent placement etc.), and Functional patency of study fistula or graft access (total duration in which it was used)."

Answered by AI

How many healthcare facilities are administering this clinical experiment in the city?

"There are 8 medical centres partaking in this clinical trial. Examples include UCLA in Los Angeles, University of Alabama at Birmingham School of Medicine in Birmingham and Cleveland Clinic Glickman Urological and Kidney Institute in Cleveland. An additional 6 sites can also be found across the United States."

Answered by AI

What is the aggregate sum of subjects participating in this experiment?

"To successfully launch this medical trial, 262 participants that meet the given criteria must be recruited. Potential enrollees can find locations in both Los Angeles and Birmingham. Specifically, UCLA in California or University of Alabama at Birmingham School of Medicine respectively."

Answered by AI

Are there opportunities to participate in this exploration?

"Affirmative. Clinicaltrials.gov lists this clinical trial as actively accepting patients, with its initial posting on August 18th 2022 and most recent update occurring on November 11th 2022. The researchers behind the project are aiming to recruit 262 participants from 8 separate medical centres for their study."

Answered by AI

Who else is applying?

What site did they apply to?
Prisma Health Upstate
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Arteriovenous Vascular (AV) ACCESS Trial
2022. "The Arteriovenous Vascular (AV) ACCESS Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04646226.
~67 spots leftby Jun 2027
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