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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
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.
The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Suzhou, Jiangsu, China
RECRUITINGMaturity rate of arteriovenous fistula
Puncture segment venous diameter
Time frame: 12 weeks after enrollment
Maturity rate of arteriovenous fistula
Brachial artery blood flow rate
Time frame: 12 weeks after enrollment
Changes in hemodynamic parameters
Blood flow
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Minimum outflow venous diameter
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Primary patency rate
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Changes in hemodynamic parameters
Secondary patency rate
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
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