Actively Recruiting
Single-Needle Distal Return for Long-Term Arteriovenous Fistula Care
Led by Suzhou Municipal Hospital of Anhui Province · Updated on 2026-01-28
100
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: For millions of people worldwide with kidney failure, a well-functioning vascular access, like an arteriovenous fistula (AVF), is essential for life-sustaining hemodialysis. However, the standard method requires puncturing the same AVF with two needles three times a week, which over time can damage the vessel, leading to scarring, narrowing, and frequent failures. These complications often require repeated surgical or minimally invasive procedures (reinterventions), causing significant pain, high medical costs, and exhaustion of the patient's limited blood vessels. New Approach: This study will evaluate a modified puncture technique called the Single-Needle Distal Return (SNDR) strategy for long-term AVF care. Instead of using two needles in the AVF, only one needle is placed in the AVF to draw blood. The cleaned blood is then returned to the body through a second needle placed in a superficial vein in the foot or lower leg. This approach aims to reduce trauma to the critical AVF. Study Plan: This is a clinical study conducted at the Blood Purification Center of Anhui Medical University Affiliated Suzhou Hospital. We plan to enroll approximately 50 adult hemodialysis patients who use an AVF and are willing to try the SNDR technique. For comparison, we will also observe data from a similar number of patients receiving standard two-needle AVF care during the same period. The study will last about three years. We will closely monitor patients using the SNDR technique to assess: Effectiveness: Whether dialysis remains adequate (measured by Kt/V). Safety: Rates of complications (like bruising or infection), dialysis machine alarms, and venous pressure during treatment. Practical Benefits: Whether it reduces the need for repair procedures (reinterventions) and hospitalizations related to the AVF. Economic Impact: Changes in healthcare costs. Patient Experience: Patient tolerance and comfort with the technique. We will also analyze the characteristics of patients who successfully use this technique long-term to help identify who might benefit most from it in the future. Potential Significance: If proven successful and safe for long-term use, the SNDR strategy could help protect a patient's precious AVF, potentially reducing painful procedures, lowering costs, slowing down the exhaustion of blood vessels, and improving the quality of life for people on long-term dialysis. The findings may also guide better planning for vascular access care.
CONDITIONS
Official 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 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 venous return cannulation
- Willingness to try the single-needle distal return method (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 vein sites
- Severe coagulation disorders or low platelet count (below 50 x 10^9/L)
- Severe peripheral arterial disease or venous insufficiency in lower extremities
- Unstable cardiovascular conditions such as uncontrolled heart failure or severe arrhythmias
- Severe cognitive impairment, psychiatric illness, or inability to provide informed consent
- Life expectancy under 12 months due to non-kidney diseases
- Currently pregnant 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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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
CONTACT
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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