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Catheter vs Fistula for Hemodialysis in Kidney Failure (ACCESS HD Trial)

N/A

Recruiting

Led By Rob Quinn, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Started hemodialysis using a tunnelled, or non-tunnelled catheter for vascular access AND ≤ 1 previously unsuccessful fistula attempt; OR changing over from peritoneal dialysis AND no functioning arteriovenous fistula available at HD start

Adult patients age ≥ 55 (AUS sites: adult patients age ≥ 65)

Must not have

Started hemodialysis with a fistula or have a patent fistula already in place or had >1 unsuccessful attempt (AUS sites: or previously functioning fistula no longer working)

Has had a prior arteriovenous graft creation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe and feasible to randomly assign elderly patients with end-stage kidney failure starting hemodialysis to either an intervention group, who will have an attempt at fistula creation, or a comparator group, who will continue to use a catheter. A total of 100 participants will be enrolled in the trial. The results of this trial will be used to determine whether a larger trial should be conducted.

Who is the study for?

This trial is for elderly patients aged 55 or older (65 in Australia) who have started hemodialysis with a catheter due to end-stage kidney failure and are either new to dialysis or switching from peritoneal dialysis without a working fistula. They should be stable, able to consent, planning to stay at the current center for 6+ months, and eligible for a fistula attempt.

What is being tested?

The ACCESS HD trial is comparing two methods of vascular access in elderly patients starting hemodialysis: creating an arteriovenous fistula versus continuing with a catheter. It's designed as an open-label randomized controlled trial across multiple centers involving 100 participants initially.

What are the potential side effects?

Potential side effects may include complications related to catheter use such as infections or blockages, and issues arising from fistula creation like clotting or poor blood flow. The specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

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

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I started hemodialysis with a catheter and had at most one failed fistula attempt, or I switched from peritoneal dialysis without a working fistula.

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I am 55 years or older (or 65+ if in Australia).

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My kidneys are failing and not expected to recover.

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I am on or will be starting hemodialysis.

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I plan to stay at my current dialysis center for at least 6 months.

Exclusion Criteria

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

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I am on hemodialysis with a fistula, or have tried and failed to get one.

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I have had surgery to create a connection between an artery and vein.

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I am scheduled for a transplant within the next 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Descriptive; reasons for delayed access to fistula surgery (feasibility)

Descriptive; reasons for exclusion of all screened participants (feasibility)

Descriptive; reasons people are considered ineligible for a fistula attempt (feasibility)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FistulaExperimental Treatment1 Intervention

Fistula is a type of vascular access strategy for hemodialysis in which a direct connection of an artery to a vein is created. It is intended to provide an access with good blood flow that can last for decades.

Group II: CatheterActive Control1 Intervention

Catheter is a method of vascular access for hemodialysis. It consists of a long, thin plastic tube and may be either tunnelled or non-tunnelled.

0 / 8Eligibility criteria met