Evaluating low-intensity pulse ultrasound for improving arteriovenous fistula maturation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Qiang Chen
• Email: chenqjs@126.com
• Phone: +8618901547679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.