About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (age ≥ 18 years).
Disqualifiers
Active systemic infection or localized infection at the potential cannulation sites (AVF or lower extremity veins).
Trial design
Parallel
Treatments tested in this trial
Single-Needle Distal Return (SNDR) Cannulation
Procedure/SurgeryFor each hemodialysis session, only a single needle is used to cannulate the arteriovenous fistula (AVF) to establish arterial blood inflow. The venous return is established by cannulating a superficial vein in the distal lower extremity (such as the dorsal foot vein or a tributary of the great saphenous vein), which is separate from the AVF. This approach aims to minimize repetitive trauma to the AVF segment itself.
Standard Two-Needle AVF Cannulation
Procedure/SurgeryFor each hemodialysis session, the established standard of care is followed. This involves cannulating the arteriovenous fistula (AVF) with two separate needles: one placed proximally (or in the arterial segment) to establish blood inflow, and a second placed distally (or in the venous segment) to return dialyzed blood. This is the conventional method for maintenance hemodialysis via an AVF.
Treatment groups
Trial outcomes
Primary outcomes
Change in dialysis adequacy (single-pool Kt/V) from baseline to study completion.
Annualized rate of access-related reinterventions (e.g., angioplasty, thrombectomy, surgical revision).
Secondary outcomes
Total access-related healthcare costs per patient-year.
Rate of hospitalizations primarily due to vascular access complications.
Incidence of cannulation-related adverse events (e.g., hematoma, infection, severe bleeding).
Proportion of hemodialysis sessions with significant machine alarms requiring staff intervention.
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