The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF

Last updated: May 13, 2024
Sponsor: Suzhou Municipal Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure (Pediatric)

Nephropathy

Kidney Failure

Treatment

Low intensity pulse ultrasound (LIPUS) intervention for arteriovenous fistula anastomosis

Clinical Study ID

NCT06249373
K-2023-094
  • Ages 18-75
  • All Genders

Study Summary

This study aims to evaluate the effect of 12 week low-intensity pulse ultrasound (LIPUS) intervention on the maturation of newly constructed autologous arteriovenous fistulas in uremic patients. This study is a prospective, blinded, randomized controlled trial. This trial is divided into two stages. The first stage is a concept validation trial, which is a single center, prospective, blinded, randomized controlled clinical study. Subjects who meet the screening criteria are randomly divided into an intervention group and a control group in a 1:1 ratio. All subjects underwent safety and efficacy evaluations at the 2nd, 4th, 8th, 12th, and 4th week after treatment. After completing a 4-week follow-up of the 20th study subject, an analysis was conducted with the preset goal of achieving a higher maturation rate of arteriovenous fistula in the intervention group compared to the control group at the follow-up point, and the safety of the study was evaluated. The second stage is a key trial, which is a multicenter, prospective, blinded, randomized controlled clinical study. The inclusion criteria, primary and secondary endpoints, and safety endpoints of the study subjects remain unchanged, and the safety and efficacy of the overall population are evaluated.

Eligibility Criteria

Inclusion

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;

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

  2. Sign an informed consent form.

Exclusion

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 peritonealdialysis 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 aslevel 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 arbitrarilychanged the types and dosages of other anticoagulants or anticoagulants (such asaspirin, 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 withmalignant 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 ofthis study.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Low intensity pulse ultrasound (LIPUS) intervention for arteriovenous fistula anastomosis
Phase:
Study Start date:
February 26, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital

    Suzhou, Jiangsu
    China

    Active - Recruiting

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