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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights
ACCESS HD Trial 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.Check my eligibility
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.See study design
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.
ACCESS HD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I started hemodialysis with a catheter and had at most one failed fistula attempt, or I switched from peritoneal dialysis without a working fistula.
Select...
I am 55 years or older (or 65+ if in Australia).
Select...
My kidneys are failing and not expected to recover.
Select...
I am on or will be starting hemodialysis.
Select...
I plan to stay at my current dialysis center for at least 6 months.
ACCESS HD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility; proportion of eligible people who are randomized (at least 25%)
Feasibility; proportion of those randomized to the intervention arm receiving a fistula attempt within 90 days of randomization (at least 80%)
Secondary outcome measures
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 moreACCESS HD 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.
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,054 Total Patients Enrolled
Applied Health Research CentreOTHER
22 Previous Clinical Trials
70,936 Total Patients Enrolled
The George InstituteOTHER
76 Previous Clinical Trials
265,754 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mentally stable and able to make my own medical decisions since starting hemodialysis.I started hemodialysis with a catheter and had at most one failed fistula attempt, or I switched from peritoneal dialysis without a working fistula.I am on hemodialysis with a fistula, or have tried and failed to get one.My doctor thinks I have less than 6 months to live due to my condition.My medical team has approved me for a fistula procedure.I have had surgery to create a connection between an artery and vein.I am 55 years or older (or 65+ if in Australia).My kidneys are failing and not expected to recover.I am on or will be starting hemodialysis.I have been on hemodialysis for a year or less.I am scheduled for a transplant within the next 6 months.I plan to stay at my current dialysis center for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Catheter
- Group 2: Fistula
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What results is this experiment hoping to produce?
"This trial will span a 42 month timeline and its primary outcome of interest is the feasibility metric, i.e., the proportion of those randomized to receive an intervention attempt within 90 days (reaching at least 80%). Secondary outcomes encompass descriptive data such as reasons for ineligibility or refusal; additionally, investigators will collect information on drop-outs and their respective causes."
Answered by AI
Are there currently any open slots for participants in this trial?
"The public clinical trial registry displays that this study is currently actively seeking participants. This investigation, initially posted on May 1st 2016 and most recently revised on July 18th 2022, requires enrolment from patients."
Answered by AI
How many volunteers have been accepted for this clinical experiment?
"Affirmative. Clinicaltrials.gov records reveal that this medical experiment, which was first launched on the 1st of May 2016, is still looking for volunteers. A total of one-hundred patients need to be enrolled from four different clinical sites."
Answered by AI
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