Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06550479

Comparison of Three Types of Distal Arteriovenous Fistulas: Snuffbox Fistula (SBAVF), Radiocephalic Fistula (RCAVF), and RCAVF With Venous Branch Patch

Led by Wroclaw Medical University · Updated on 2024-08-13

180

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 patient's 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

Brief Title

Comparison of Three Types of Distal Arteriovenous Fistulas: SBAVF, RCAVF, and RCAVF With Venous Branch Patch.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged >18 years
  • Chronic kidney disease with estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m2
  • Undergoing arteriovenous fistula creation with venous end-to-arterial side anastomosis in the upper limb
Not Eligible

You will not qualify if you...

  • Heart failure of New York Heart Association functional class III or IV
  • Recent cardio- or cerebrovascular event or intervention therapy within 3 months prior to screening
  • Previous primary anastomosis on the same arm

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-operative Follow-up

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

Follow-up Monitoring

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

Trial Site Locations

Total: 1 location

1

Department of Nephrology and Transplantation Medicine

Wroclaw, Poland, 50-556

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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