Evaluating low-intensity pulse ultrasound for improving arteriovenous fistula maturation

A Multicenter Randomized Controlled Trial on the Effect of Low-intensity Pulsed Ultrasound on the Maturation of Newly Constructed Autogenous Arteriovenous Fistulas in Uremic Patients

This study is testing if low-intensity pulse ultrasound can help improve the growth of new arteriovenous fistulas in patients with chronic kidney disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Municipal Hospital (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06249373 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of low-intensity pulse ultrasound (LIPUS) on the maturation of newly constructed autologous arteriovenous fistulas in patients with chronic uremia. It is a prospective, blinded, randomized controlled trial divided into two stages, with participants randomly assigned to either an intervention or control group. The study aims to assess safety and efficacy at multiple follow-up points over a 12-week period, focusing on achieving a higher maturation rate in the intervention group compared to the control group.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 75 with newly established autologous arteriovenous fistulas who have not yet begun hemodialysis.

Not a fit: Patients with poor healing of internal structures or those who do not meet the specified ultrasound criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could enhance the maturation rates of arteriovenous fistulas, leading to improved dialysis access for patients with chronic kidney disease.

How similar studies have performed: While the use of LIPUS in this context is relatively novel, similar studies have shown promise in enhancing tissue healing and maturation in other medical applications.

Eligibility criteria

Inclusion Criteria:

1.18 years old ≤ Age ≤ 75 years old, regardless of gender or ethnicity;

2.Dialysis or non-dialysis patients who have newly established autologous arteriovenous fistula in the wrist and have not yet used the fistula for hemodialysis treatment;

3.Before establishing an autologous arteriovenous fistula in the wrist, ultrasound examination will be performed. The radial artery diameter at the intended surgical site is\>1.5mm, and the head vein diameter is\>2mm （using a tourniquet）. The arterial and venous blood flow are unobstructed, and the distance between the vein and the skin is\<6mm;

4\. After introducing dialysis, the calcium ion concentration in the dialysate will be maintained at 1.5mmol/L during the dialysis period, and low molecular weight heparin will be used for anticoagulation. The dosage of low molecular weight heparin remains unchanged （±1000U） during the study period;

5\. Sign an informed consent form.

Exclusion Criteria:

1. Poor healing of internal fistula surgical incision;
2. Active bacterial or viral infections;
3. Pregnant women;
4. The patient underwent kidney transplantation or was transferred to peritoneal dialysis during the study period;
5. Subject ALT, AST ≥ 3 × upper limit of normal values;
6. Within 3 months, according to NYHA classification, heart function is classified as level III-IV;
7. Newly diagnosed unstable angina and cerebrovascular events within 3 months;
8. Blood pressure below 90/60mmHg or above 180/100mmHg in the past 2 weeks;
9. During the study period, patients did not follow medical advice and arbitrarily changed the types and dosages of other anticoagulants or anticoagulants (such as aspirin, clopidogrel, Agat Roban, etc.);
10. Combine the use of glucocorticoids and immunosuppressants, such as tacrolimus, cyclosporine, MMF, azathioprine, leflunomide, Tripterygium wilfordii glycosides, etc;
11. Other researchers consider inappropriate situations, such as coexisting with malignant tumors, where the expected lifespan is less than 6 months;
12. I have participated in other clinical trials within 4 weeks prior to the start of this study.

Where this trial is running

Suzhou, Jiangsu

• The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Qiang Chen

Conditions Uremia; Chronic