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Hemodialysis Access Techniques for Chronic Kidney Disease in the Elderly (ELDERLY Trial)

N/A

Recruiting

Led By Eric K Peden, MD

Research Sponsored by E. Peden, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Expected to undergo hemodialysis within 6 months of presentation

Aged ≥70 years of all ethnicities

Must not have

Intraoperative decision was made in favor of fistula instead of graft

Unable or refuse to abide with follow-up

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial will compare autologous arteriovenous fistulas (AVF) to hemodialysis access grafts in the elderly, enrolling 270 patients over 5 years.

Who is the study for?

This trial is for people aged 70 or older with advanced kidney disease who need hemodialysis and can have surgery to create a dialysis access. They must be currently on hemodialysis due to previous access failure, and not have bleeding disorders, active infections, certain vein issues unless recently imaged, or an inability to follow the study plan.

What is being tested?

The study compares two surgical methods for creating dialysis access in elderly patients: making a fistula from their own blood vessels or implanting a synthetic graft. It's randomized-controlled, meaning participants are randomly assigned to one of these two groups without knowing which one.

What are the potential side effects?

Possible side effects include complications at the surgery site like infection or clotting, problems with blood flow through the created access point leading to additional interventions, and general risks associated with anesthesia and surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am expected to start hemodialysis within the next 6 months.

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I am 70 years old or older.

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My blood vessels are suitable for creating a connection for dialysis.

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I am on hemodialysis due to previous access failure.

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I have severe kidney disease and need dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My surgery involved creating a fistula instead of using a graft.

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I cannot or will not follow the study's follow-up requirements.

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I have a condition that affects how my blood clots.

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I do not have any active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.

Functional cumulative patency rate at 12 months

Secondary study objectives

To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.

Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to morbidity in the 2 years post fistula/graft procedure

Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to mortality in the 2 years post fistula/graft procedure

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Surgical graft implantActive Control2 Interventions

Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.

Group II: Surgical fistula creation from patient's anatomyActive Control1 Intervention

Patients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

E. Peden, MDLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

281 Previous Clinical Trials

81,336 Total Patients Enrolled

1 Trials studying Kidney Failure

99 Patients Enrolled for Kidney Failure

Eric K Peden, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Media Library

Surgical fistula creation from patient's anatomy Clinical Trial Eligibility Overview. Trial Name: NCT03065972 — N/A

Kidney Failure Research Study Groups: Surgical graft implant, Surgical fistula creation from patient's anatomy

Kidney Failure Clinical Trial 2023: Surgical fistula creation from patient's anatomy Highlights & Side Effects. Trial Name: NCT03065972 — N/A

Surgical fistula creation from patient's anatomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03065972 — N/A

~10 spots leftby Feb 2025

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