Actively Recruiting
The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
Led by Suzhou Municipal Hospital · Updated on 2024-05-16
300
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
S
Suzhou Municipal Hospital
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender or ethnicity
- Dialysis or non-dialysis patients with newly created autologous arteriovenous fistula in the wrist not yet used for hemodialysis
- Radial artery diameter at surgical site greater than 1.5 mm and head vein diameter greater than 2 mm using a tourniquet
- Arterial and venous blood flow unobstructed
- Distance between vein and skin less than 6 mm
- Stable dialysis conditions with calcium ion concentration maintained at 1.5 mmol/L and consistent low molecular weight heparin anticoagulation during dialysis
- Signed informed consent form
You will not qualify if you...
- Poor healing of internal fistula surgical incision
- Active bacterial or viral infections
- Pregnant women
- Kidney transplantation or switch to peritoneal dialysis during the study
- ALT or AST levels three times above the upper normal limit
- Heart function classified as NYHA level III-IV within past 3 months
- Newly diagnosed unstable angina or cerebrovascular events within past 3 months
- Blood pressure below 90/60 mmHg or above 180/100 mmHg in past 2 weeks
- Non-compliance with medical advice regarding anticoagulant use during the study
- Use of glucocorticoids and immunosuppressants like tacrolimus, cyclosporine, MMF, azathioprine, leflunomide, Tripterygium wilfordii glycosides
- Coexisting malignant tumors with expected lifespan less than 6 months
- Participation in other clinical trials within 4 weeks prior to study start
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
Q
Qiang Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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