Single-Needle Distal Return for Long-Term Arteriovenous Fistula Care

Summary

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

• Hemodialysis Access
• Arteriovenous Fistula
• Arteriovenous Fistula Cannulation
• Vascular Access
• Vascular Access Complication

Interventions

PROCEDURE

Single-Needle Distal Return (SNDR) Cannulation

For 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.

PROCEDURE

Standard Two-Needle AVF Cannulation

For 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.

Sponsors & Collaborators

• Suzhou Municipal Hospital of Anhui Province

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-12-15

Primary Completion

2026-12-20

Completion

2026-12-31

Countries

• China

Study Locations