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New treatment option for Chronic Kidney Disease Requiring Hemodialysis
Official title Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.
ClinicalTrials.gov ID: NCT06997042
What this study is testing
- What it's testing
- This study is designed to compare two surgical techniques used to create arteriovenous fistulas (AVFs), which are necessary for hemodialysis in patients with advanced chronic kidney disease (CKD). AVFs are preferred over other forms of vascular access because they last longer and have fewer complications.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years
- Able to meet protocol requirements, including follow-up.
- Incident or prevalent patient with advanced chronic kidney disease in the hemodialysis stage (stage 5D).
- In predialysis patients (stage 5), if renal replacement therapy (hemodialysis) is anticipated to be required within the next 6 months (based on...
- Who, based on their associated pathology and according to medical criteria, can withstand the initial surgery and arteriovenous access maintenance...
You likely can't join if
- Pregnant women.
- Life expectancy \<1 year.
- Arteriovenous prostheses (non-native fistulas), previous arteriovenous fistula repairs, arteriovenous accesses created in the lower extremities, and...
- Known or suspected central venous stenosis/occlusion on the side of the planned access.
- Repair of previous arteriovenous accesses (proximal reanastomoses).
- Biological immunosuppression.
See the full eligibility criteria
- Age \> 18 years
- Able to meet protocol requirements, including follow-up.
- Incident or prevalent patient with advanced chronic kidney disease in the hemodialysis stage (stage 5D).
- In predialysis patients (stage 5), if renal replacement therapy (hemodialysis) is anticipated to be required within the next 6 months (based on standard clinical criteria).
- Who, based on their associated pathology and according to medical criteria, can withstand the initial surgery and arteriovenous access maintenance procedures.
- Have a current ultrasound with preoperative venous and arterial mapping.
- Meet the anatomical requirements for AVF creation:
- Wrist: artery \>2 mm, vein \>2 mm in diameter
- Elbow: artery \>3 mm, vein \>3 mm in diameter
- Absence of arterial calcification or occlusion, or other aberrant arterial anatomy.
- Adequate arterial and venous patency.
- Vein-to-skin distance \<5 mm.
- Candidate for creation of a native arteriovenous fistula for hemodialysis, either distal (radiocephalic) or proximal (humerocephalic or humerobasilic).
- No immediate transplant scheduled within the next 60 days (inclusion on the kidney transplant waiting list is not a contraindication for entry into the study, nor for the creation of an arteriovenous fistula).
- No prior arteriovenous surgeries in the same or proximal location.
- Correct understanding of the study conditions and acceptance to participate.
- Pregnant women.
- Life expectancy \<1 year.
- Arteriovenous prostheses (non-native fistulas), previous arteriovenous fistula repairs, arteriovenous accesses created in the lower extremities, and unusual (exotic) accesses.
- Known or suspected central venous stenosis/occlusion on the side of the planned access.
- Repair of previous arteriovenous accesses (proximal reanastomoses).
- Biological immunosuppression.
- History or evidence of serious systemic illness, including:
- Cardiac disease (New York Heart Association functional class III or IV, as evidenced by the inability to lie still), myocardial infarction within 6 weeks prior to randomization, ventricular tachyarrhythmia requiring...
- Any other condition that, in the investigator's judgment, prevents an adequate evaluation of the safety and how well it works of the study or poor compliance.
- Patient unwilling or unable to attend follow-up follow-ups.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.