Dialysis dilemma: which access surgery is safer for seniors?
NCT ID NCT04646226
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for End-stage kidney disease are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can pedaling during dialysis make red blood cells more flexible?
- Fewer dialysis sessions: can Twice-Weekly work as well?
- Can pedaling through dialysis make patients stronger?
- Can music make dialysis exercise more effective?
- Can a daily antibiotic shield dialysis patients from deadly infections?
- Warming donated kidneys may boost transplant success