Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.
Recruiting · NCT06997042 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital Clinic of Barcelona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. However, many AVFs fail to mature properly, making them unusable for dialysis. The two techniques being studied are the traditional End-to-Side (ETS) method and a newer technique called Piggyback Straight Line Onlay Technique (pSLOT). Early studies suggest that pSLOT may reduce complications like narrowing (stenosis), clotting (thrombosis), and failure of the AVF, but more robust data from randomized clinical trials is needed. Patients aged 18 or older with stage 4 or 5 CKD, who are eligible for a new AVF and meet health criteria, may participate. During the operation, participants are randomly assigned to receive either the ETS or pSLOT technique. The procedure is done under local or regional anesthesia. Follow-up appointments are scheduled at 1 and 12 months to assess fistula maturation, blood flow, and whether it can be successfully used for dialysis. Remote follow-ups are allowed if needed. Participation is voluntary, requires informed consent, and all data is kept strictly confidential. The study follows national and international ethical standards and has been approved by an ethics committee.
Who can take part
Inclusion 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Hospital Clínic de Barcelona - Barcelona, Barcelona, Spain