The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
ConditionUremia; Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Municipal Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Poor healing of internal fistula surgical incision;
Active bacterial or viral infections;
Pregnant women;
The patient underwent kidney transplantation or was transferred to peritoneal dialysis during the study period;
Trial design
Design model
Parallel
Treatments tested in this trial
Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis
DeviceThe 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: LIPUS intervention groupExperimental treatment 1 intervention
Group B: Simulated LIPUS control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Maturity rate of arteriovenous fistula
Puncture segment venous diameter
Time frame
12 weeks after enrollment2
Maturity rate of arteriovenous fistula
Brachial artery blood flow rate
Time frame
12 weeks after enrollmentSecondary outcomes
1
Changes in hemodynamic parameters
Blood flow
Time frame
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.2
Changes in hemodynamic parameters
Minimum outflow venous diameter
Time frame
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.3
Changes in hemodynamic parameters
Primary patency rate
Time frame
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.4
Changes in hemodynamic parameters
Secondary patency rate
Time frame
2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Suzhou Municipal Hospital
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Second Affiliated Hospital of Soochow University
Collaborator
Dushu Lake Hospital Affiliated to Soochow University
Collaborator
Source ClinicalTrials.gov