Hemodialysis AccessNCT07372027
Single-Needle Distal Return for Long-Term Arteriovenous Fistula Care
A study testing Single-Needle Distal Return (SNDR) Cannulation and Standard Two-Needle AVF Cannulation in people with Hemodialysis Access and Arteriovenous Fistula, run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemodialysis Access, Arteriovenous Fistula, Arteriovenous Fistula Cannulation
- What is being tested?
- Single-Needle Distal Return (SNDR) Cannulation and Standard Two-Needle AVF Cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Hospital Affiliated to Anhui Medical University
Suzhou, Anhui
Shan Wu, 86-0557-2560020, keyanchu3089@163.com
About this study
Official title: 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
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.
Read more
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
- Being tested
- Single-Needle Distal Return (SNDR) Cannulation, Standard Two-Needle AVF Cannulation
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Needle Distal Return (SNDR) CannulationProcedure or surgery
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.
Standard Two-Needle AVF CannulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-Needle Distal Return | Experimental | Not described Receives: Procedure: Single-Needle Distal Return (SNDR) Cannulation |
| Standard Two-Needle AVF Cannulation | Active comparator | Not described Receives: Procedure: Standard Two-Needle AVF Cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dialysis adequacy (single-pool Kt/V) from baseline to study completion.
Measured: From enrollment to the end of the 24-month follow-up period.
Annualized rate of access-related reinterventions (e.g., angioplasty, thrombectomy, surgical revision).
Measured: From enrollment to the end of the 24-month follow-up period.
Secondary outcomes (5)
Total access-related healthcare costs per patient-year.
Measured: From enrollment to the end of the 24-month follow-up period.
Rate of hospitalizations primarily due to vascular access complications.
Measured: From enrollment to the end of the 24-month follow-up period.
Incidence of cannulation-related adverse events (e.g., hematoma, infection, severe bleeding).
Measured: Assessed at each hemodialysis session throughout the study, up to 24 months.
Proportion of hemodialysis sessions with significant machine alarms requiring staff intervention.
Measured: Assessed at each hemodialysis session throughout the study, up to 24 months.
Patient-reported tolerance and satisfaction assessed via a standardized questionnaire.
Measured: At 6 months, 12 months, and at study completion (24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start15 Dec 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital of Anhui Province
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372027
- Sponsor's protocol ID
- ASZH-2024-CS-HD-SNC-01
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07372027
- Acronym / sponsor ID
- ASZH-2024-CS-HD-SNC-01
- Conditions
- Hemodialysis Access, Arteriovenous Fistula, Arteriovenous Fistula Cannulation, Vascular Access, Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Suzhou Municipal Hospital of Anhui ProvinceUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Needle Distal Return | Experimental | Procedure: Single-Needle Distal Return (SNDR) Cannulation |
| Standard Two-Needle AVF Cannulation | Active comparator | Procedure: Standard Two-Needle AVF Cannulation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Needle Distal Return (SNDR) CannulationFor 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 or surgery | Single-Needle Distal Return |
| Standard Two-Needle AVF CannulationFor 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. | Procedure or surgery | Standard Two-Needle AVF Cannulation |
Primary outcome
Change in dialysis adequacy (single-pool Kt/V) from baseline to study completion.
Time frame: From enrollment to the end of the 24-month follow-up period.
Annualized rate of access-related reinterventions (e.g., angioplasty, thrombectomy, surgical revision).
Time frame: From enrollment to the end of the 24-month follow-up period.
5 secondary outcomes
Total access-related healthcare costs per patient-year.
Time frame: From enrollment to the end of the 24-month follow-up period.
Rate of hospitalizations primarily due to vascular access complications.
Time frame: From enrollment to the end of the 24-month follow-up period.
Incidence of cannulation-related adverse events (e.g., hematoma, infection, severe bleeding).
Time frame: Assessed at each hemodialysis session throughout the study, up to 24 months.
Proportion of hemodialysis sessions with significant machine alarms requiring staff intervention.
Time frame: Assessed at each hemodialysis session throughout the study, up to 24 months.
Patient-reported tolerance and satisfaction assessed via a standardized questionnaire.
Time frame: At 6 months, 12 months, and at study completion (24 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Needle Distal Return (SNDR) Cannulation and Standard Two-Needle AVF Cannulation in people with Hemodialysis Access and Arteriovenous Fistula, run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shan Wu, Doctor of Philosophy (86-0557-3032255, 2671437948@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dialysis adequacy (single-pool Kt/V) from baseline to study completion. (time frame: From enrollment to the end of the 24-month follow-up period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.