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https://pubmed.ncbi.nlm.nih.gov/31253515Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06249373
A Multicenter Randomized Controlled Trial on the Effect of Low-intensity Pulsed Ultrasound on the Maturation of Newly Constructed Autogenous Arteriovenous Fistulas in Uremic Patients
Led by Suzhou Municipal Hospital · Updated on 2024-05-16
300
Participants Needed
1
Research Sites
52 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
Researchers are assessing the impact of a 12-week low-intensity pulsed ultrasound (LIPUS) treatment on the maturation of newly created autologous arteriovenous fistulas in patients with uremia. This prospective, blinded, randomized controlled trial is conducted in two stages: an initial single-center concept validation followed by a larger multicenter key trial. The study aims to compare the maturation rate of fistulas between those receiving LIPUS and a control group, ensuring safety and efficacy are carefully evaluated throughout.
CONDITIONS
Brief Title
The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender or ethnicity
- Dialysis or non-dialysis patients with a newly created autologous arteriovenous fistula in the wrist not yet used for dialysis
- Ultrasound before fistula creation shows radial artery diameter >1.5mm and head vein diameter >2mm with unobstructed blood flow and vein less than 6mm from skin
- During dialysis, dialysate calcium maintained at 1.5mmol/L and stable low molecular weight heparin dose (±1000U)
- Signed informed consent form
You will not qualify if you...
- Poor healing at the fistula surgical site
- Active bacterial or viral infections
- Pregnant women
- History of kidney transplant or switch to peritoneal dialysis during study
- Liver enzymes ALT, AST ≥ 3 times upper normal limit
- Heart function NYHA class III-IV within 3 months
- Newly diagnosed unstable angina or cerebrovascular events within 3 months
- Blood pressure below 90/60mmHg or above 180/100mmHg in past 2 weeks
- Changing anticoagulant medications during study without medical advice
- Use of glucocorticoids or immunosuppressants like tacrolimus, cyclosporine, MMF, azathioprine, leflunomide, or Tripterygium wilfordii glycosides
- Malignant tumors with expected survival less than 6 months
- Participation in another clinical trial within 4 weeks prior to study start
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive low-intensity pulsed ultrasound (LIPUS) intervention at the arteriovenous fistula site starting no more than 3 days after suture removal, three times a week during dialysis sessions, each lasting 20 minutes, for a total treatment period of 12 weeks.
Three times a week during dialysis sessions
Follow-up
Duration - 4 weeks
Participants are monitored for changes in hemodynamic parameters and the maturity of the arteriovenous fistula after completing the treatment period.
1 visit 4 weeks after treatment completion
Trial Site Locations
Total: 1 location
1
The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Actively Recruiting
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Research Team
Q
Qiang Chen
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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