Uremia; Chronic
Conditions
Brief 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.
Interventions
DEVICELow 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.
Sponsors
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
Suzhou Municipal Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maturity rate of arteriovenous fistula | 12 weeks after enrollment | Puncture segment venous diameter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hemodynamic parameters | 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up. | Blood flow |
Countries
China
Contacts
Primary ContactQiang Chen
Outcome results
None listed