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Dialysis dilemma: which access surgery is safer for seniors?

NCT ID NCT04646226

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of surgery to create dialysis access in older adults (60+) with end-stage kidney disease. One method connects a vein directly to an artery (fistula), the other uses a synthetic tube (graft). The goal is to see which leads to fewer infections and more days without a temporary catheter. 103 participants are being followed to guide better care for seniors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical procedure (fistula or graft creation)
What this could lead to
If successful, this could help doctors choose the better type of dialysis access for older patients, reducing infections and time on catheters.
What could go wrong
This is a small, early-stage trial with only 103 participants, so results may not apply to all patients. Both procedures carry risks like infection or clotting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

103 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 60 years or older * End-stage kidney disease on hemodialysis via a central venous catheter * Hemodialysis is the long-term modality of treatment for end-stage kidney disease * Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation * Referred by patient's nephrologist for placement of arteriovenous access * At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus * Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers * Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon * Patient agreed to study participation and signed the informed consent Exclusion Criteria: * Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device * Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization * Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices) * Anticipated kidney transplant within 12 months * Anticipated conversion to peritoneal dialysis within 12 months * Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months * Anticipated non-compliance with medical care based on physician judgment * A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Atrium Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21205, United States

  • Prisma Health Upstate

    Greenville, South Carolina, 29601, United States

  • UCLA

    Los Angeles, California, 90095, United States

  • University of Alabama at Birmingham School of Medicine

    Birmingham, Alabama, 35487, United States

  • University of Tennessee Medical Center at Knoxville

    Knoxville, Tennessee, 37920, United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53726, United States

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