Status:
RECRUITING
Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Chronic Kidney Disease Requiring Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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). AVF...
Detailed Description
Creation of Arteriovenous Fistulas for Hemodialysis: End-to-Side vs. Piggyback Anastomosis - A Randomized Clinical Trial 1. Background and Rationale Chronic Kidney Disease (CKD) affects an estima...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 ongoing treatment, or unstable angina.
- Suspected or documented hypercoagulable or hypocoagulable state or Clinically significant active infection (White blood count \> 15,000 cells/mm3) other than the use of a treated CVC.
- Any other condition that, in the investigator's judgment, prevents an adequate evaluation of the safety and efficacy of the study or poor compliance.
- Patient unwilling or unable to attend follow-up follow-ups.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06997042
Start Date
May 1 2025
End Date
December 1 2027
Last Update
September 18 2025
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08018