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

May 13, 2024 updated by: Qiang Chen, Suzhou Municipal Hospital

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIPUS intervention group
Low intensity pulse ultrasound （LIPUS） intervenes at the anastomotic site, and if the ultrasound examination indicates the presence of a narrow site in the outflow tract, it also intervenes at the narrow site. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.
Device: Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis
The LIPUS intervention group for arteriovenous fistula should receive forearm wearable portable low-intensity pulse ultrasound （LIPUS） intervention at the anastomotic site no more than 3 days after suture removal two weeks after the fistula surgery. If the ultrasound examination indicates the presence of stenosis in the outflow tract, the intervention should also be performed at the same time. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.
No Intervention: Simulated LIPUS control group
Using the same forearm wearable portable ultrasound as the LIPUS arteriovenous fistula intervention group, but not issuing low-intensity pulse ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maturity rate of arteriovenous fistula
Time Frame: 12 weeks after enrollment
Puncture segment venous diameter
12 weeks after enrollment
Maturity rate of arteriovenous fistula
Time Frame: 12 weeks after enrollment
Brachial artery blood flow rate
12 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hemodynamic parameters
Time Frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Blood flow
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Time Frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Minimum outflow venous diameter
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Time Frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Primary patency rate
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Time Frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Secondary patency rate
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Municipal Hospital

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of Soochow University
Second Affiliated Hospital of Soochow University
Dushu Lake Hospital Affiliated to Soochow University

Investigators

  • Study Chair: Xiangqing Kong, Suzhou Municipal Hospital
  • Study Director: Huijuan Mao, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-2023-094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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