The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
NCT ID: NCT06249373
Last Updated: 2024-05-16
Study Results
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Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-02-26
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Second Affiliated Hospital of Soochow University
OTHER
Dushu Lake Hospital Affiliated to Soochow University
OTHER
Suzhou Municipal Hospital
OTHER
Responsible Party
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Qiang Chen
Head of Nephrology
Principal Investigators
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Xiangqing Kong
Role: STUDY_CHAIR
Suzhou Municipal Hospital
Huijuan Mao
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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K-2023-094
Identifier Type: -
Identifier Source: org_study_id
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