Actively Recruiting
A Prospective Study on the Efficacy and Cost-Effectiveness of Modified Single-Needle Distal Return Cannulation for Long-Term Arteriovenous Fistula Care in Maintenance Hemodialysis Patients
Led by Suzhou Municipal Hospital of Anhui Province · Updated on 2026-01-28
100
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Millions of people with kidney failure rely on a well-functioning arteriovenous fistula (AVF) for life-sustaining hemodialysis. The usual method uses two needles to access the AVF three times a week, but this can damage the vessel over time, causing scarring and failures that require painful and costly repair procedures. This study evaluates a new technique called Single-Needle Distal Return (SNDR) that uses only one needle in the AVF and returns blood through a vein in the lower leg or foot, aiming to reduce damage to the AVF. The study will enroll about 50 adults undergoing hemodialysis with a native AVF, who agree to try the SNDR method. Another similar group will continue with the standard two-needle AVF care for comparison. Each hemodialysis session uses either the SNDR method or the standard approach. The study will last around three years, including a 24-month follow-up period to assess outcomes. Participants will be closely monitored for dialysis effectiveness, safety, and practical benefits like fewer repair procedures and hospitalizations. Researchers will measure dialysis adequacy using Kt/V, track complications such as bruising or infection, and record dialysis machine alarms. Patient comfort and satisfaction will be assessed through questionnaires at 6, 12, and 24 months. Economic impacts and patient characteristics related to successful long-term use will also be studied.
CONDITIONS
Brief Title
Single-Needle Distal Return for Long-Term Arteriovenous Fistula Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Diagnosis of end-stage kidney disease requiring maintenance hemodialysis three times per week
- Use of a native arteriovenous fistula (AVF) as the primary vascular access for at least 3 months
- Willing and able to provide written informed consent
- Adequate superficial veins in at least one lower extremity suitable for cannulation
- Willingness to adopt the single-needle distal return technique (for experimental group)
- Currently receiving and willing to continue standard two-needle AVF cannulation (for control group)
You will not qualify if you...
- Active systemic or localized infection at AVF or lower extremity veins
- Severe coagulation disorder or low platelet count increasing bleeding risk
- Severe peripheral arterial disease or venous insufficiency in lower limbs
- Unstable cardiovascular conditions increasing procedural risk
- Severe cognitive impairment or psychiatric illness affecting consent or adherence
- Life expectancy under 12 months from non-kidney illnesses
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
- Anatomical or pathological AVF conditions preventing safe single-needle cannulation
- Inability to comply with study visits and follow-up assessments
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive hemodialysis using either the Single-Needle Distal Return (SNDR) Cannulation or Standard Two-Needle AVF Cannulation methods.
Three hemodialysis sessions per week throughout the study
Duration - Up to 24 months (concurrent with treatment)
Participants are monitored for dialysis adequacy, vascular access complications, adverse events, and patient-reported outcomes.
Assessments at 6 months, 12 months, and 24 months
Trial Site Locations
Total: 1 location
1
Suzhou Hospital Affiliated to Anhui Medical University
Suzhou, Anhui, China
Actively Recruiting
Research Team
S
Shan Wu, Doctor of Philosophy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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