EBPG on Vascular Access.
Jan Tordoir, Bernard Canaud, Patrick Haage...
https://pubmed.ncbi.nlm.nih.gov/17507428/Actively Recruiting
Led by Wroclaw Medical University · Updated on 2024-08-13
180
Participants Needed
1
Research Sites
156 weeks
Total Duration
Researchers are evaluating which type of distal arteriovenous fistula SBAVF, RCAVF, or RCAVF with venous branch patch is most clinically favorable for patients with chronic kidney disease CKD stage 4 or 5 who need vascular access for hemodialysis. The study recognizes that current guidelines do not specify which fistula type should be preferred initially, and the investigation aims to clarify differences in early and late success rates and maturation among these fistula types. The study involves creating one of three types of distal arteriovenous fistulas based on the patients upper limb vascular anatomy assessed by Doppler ultrasound. Participants will be grouped into those receiving snuffbox fistula SBAVF, radiocephalic fistula RCAVF, or RCAVF with venous branch patch. The maturation of the fistula will be evaluated six weeks after surgery by measuring blood flow and vein diameter, using ultrasound to determine if the fistula is mature enough for effective hemodialysis. Participants will undergo detailed assessments including interviews for clinical history, physical examinations, and imaging studies of upper limb vessels before and after fistula creation. Blood samples and routine laboratory tests will be collected at baseline and during follow-up visits at specific intervals. The main outcomes measured are primary patency at 12 months and assisted primary and secondary patency at 36 months, with fistula maturation assessed at six weeks. Statistical analyses will compare outcomes across groups and consider patient characteristics that may influence fistula success.
CONDITIONS
Comparison of Three Types of Distal Arteriovenous Fistulas: SBAVF, RCAVF, and RCAVF With Venous Branch Patch.
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Wroclaw Medical University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus immediate recovery
Participants undergo creation of a distal arteriovenous fistula (AVF) for hemodialysis using one of three types: snuffbox fistula (SBAVF), radiocephalic fistula (RCAVF), or RCAVF with venous branch patch, based on their vascular anatomy.
1 surgical visit (in-person)
Duration - 6 weeks
Participants have ultrasound assessments and clinical evaluations to monitor AVF maturation, defined by blood flow and vein diameter, with additional lab tests and imaging as needed.
Visits on day 1 and at 6 weeks post-surgery
Duration - Up to 36 months
Participants are monitored for AVF patency and function over time, including assessments of primary, assisted primary, and secondary patency rates up to 36 months after surgery.
Periodic follow-up visits as scheduled
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/28843984/Wroclaw Medical University
Lead Sponsor