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临床试验/NCT07372027
NCT07372027招募中不适用

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

Suzhou Municipal Hospital of Anhui Province1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Change in dialysis adequacy (single-pool Kt/V) from baseline to study completion.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Single-Needle Distal Return

Experimental

干预措施: Single-Needle Distal Return (SNDR) Cannulation (Procedure)

Standard Two-Needle AVF Cannulation

Active Comparator

干预措施: Standard Two-Needle AVF Cannulation (Procedure)

结局指标

主要结局

Change in dialysis adequacy (single-pool Kt/V) from baseline to study completion.

时间窗: From enrollment to the end of the 24-month follow-up period.

Annualized rate of access-related reinterventions (e.g., angioplasty, thrombectomy, surgical revision).

时间窗: From enrollment to the end of the 24-month follow-up period.

次要结局

  • Total access-related healthcare costs per patient-year.(From enrollment to the end of the 24-month follow-up period.)
  • Rate of hospitalizations primarily due to vascular access complications.(From enrollment to the end of the 24-month follow-up period.)
  • Incidence of cannulation-related adverse events (e.g., hematoma, infection, severe bleeding).(Assessed at each hemodialysis session throughout the study, up to 24 months.)
  • Proportion of hemodialysis sessions with significant machine alarms requiring staff intervention.(Assessed at each hemodialysis session throughout the study, up to 24 months.)
  • Patient-reported tolerance and satisfaction assessed via a standardized questionnaire.(At 6 months, 12 months, and at study completion (24 months).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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