Single-needle distal return for long-term AV fistula care
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
This trial tests a single-needle method that draws blood from your arm fistula and returns it through a foot or lower-leg vein to see if it reduces damage and the need for repeat procedures in adults on thrice-weekly hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Suzhou Municipal Hospital of Anhui Province Academic / other |
| Locations | 1 site (Suzhou, Anhui) |
| Trial ID | NCT07372027 on ClinicalTrials.gov |
What this trial studies
Millions of people on maintenance hemodialysis rely on native arteriovenous fistulas (AVFs), but repeated two-needle cannulation can injure the vessel and lead to scarring, narrowing, and frequent reinterventions. This interventional study compares a Single-Needle Distal Return (SNDR) technique—one needle in the AVF with return via a superficial lower-extremity vein—against standard two-needle AVF cannulation. Participants who meet eligibility will receive either SNDR or standard cannulation and will be monitored over time for vascular access health, complications, and need for procedures. The trial aims to determine whether SNDR reduces needle-related AVF damage and downstream interventions compared with standard care.
Who should consider this trial
Good fit: Adults (age ≥18) with end-stage kidney disease on maintenance thrice-weekly hemodialysis using a native AV fistula for at least 3 months and with adequate superficial veins in a lower extremity for return cannulation.
Not a fit: Patients with active systemic or local infections, severe coagulation disorders, or without suitable lower-leg veins are unlikely to benefit or be eligible for this approach.
Why it matters
Potential benefit: If successful, SNDR could reduce needle-related damage to AV fistulas and lower the frequency of surgeries and other reinterventions.
How similar studies have performed: Single-needle dialysis and alternative return-site cannulation have been reported in small series, but long-term comparative data specifically on SNDR are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age ≥ 18 years). Diagnosis of end-stage kidney disease (ESKD) requiring maintenance hemodialysis (three times per week). Reliable use of a native arteriovenous fistula (AVF) as the primary vascular access for at least the past 3 months. Willing and able to provide written informed consent to participate in the study. Adequate superficial venous vasculature in at least one lower extremity (e.g., dorsal foot veins, saphenous tributaries) as assessed by clinical evaluation and/or bedside ultrasound, deemed suitable for cannulation as a venous return site. For the experimental (SNDR) group: Expressed willingness to adopt the single-needle distal return cannulation strategy. For the control group: Currently receiving and willing to continue standard two-needle AVF cannulation. Exclusion Criteria: * Active systemic infection or localized infection at the potential cannulation sites (AVF or lower extremity veins). Known severe coagulation disorder or thrombocytopenia (platelet count \< 50 × 10⁹/L) that would pose a high risk of bleeding complications from cannulation. Severe peripheral arterial disease or venous insufficiency in the lower extremities that contraindicates venous cannulation or may compromise limb perfusion. Unstable cardiovascular status (e.g., uncontrolled heart failure, severe arrhythmias) as determined by the treating nephrologist, which would increase the risk associated with any change in dialysis procedure. Documented severe cognitive impairment, psychiatric illness, or any condition that would impair the ability to provide informed consent or adhere to the study protocol. Life expectancy less than 12 months due to non-renal comorbid conditions (e.g., metastatic malignancy). Currently pregnant or breastfeeding. Participation in another interventional clinical trial that could confound the outcomes of this study. Anatomical or pathological condition of the AVF (e.g., extreme depth, aneurysm with overlying skin compromise, complete thrombosis) that precludes safe single-needle cannulation, as judged by the study vascular access team. Inability to comply with the scheduled study visits and follow-up assessments.
Where this trial is running
Suzhou, Anhui
- Suzhou Hospital Affiliated to Anhui Medical University — Suzhou, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Shan Wu, Doctor of Philosophy
- Email: 2671437948@qq.com
- Phone: 86-0557-3032255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.