NCT06249373Recruiting
The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
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
Source: ClinicalTrials.gov · Last updated 16 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 29 Jan 2024
- Start date
- 26 Feb 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Suzhou Municipal Hospital
- NCT number
- NCT06249373
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 26 Feb 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient underwent kidney transplantation or was transferred to peritoneal dialysis during the study period;
- I have participated in other clinical trials within 4 weeks prior to the start of this study.
Other illness
- Poor healing of internal fistula surgical incision;
- Active bacterial or viral infections;
- Within 3 months, according to NYHA classification, heart function is classified as level III-IV;
- Newly diagnosed unstable angina and cerebrovascular events within 3 months;
- Other researchers consider inappropriate situations, such as coexisting with malignant tumors, where the expected lifespan is less than 6 months;
Lab values
- Subject ALT, AST ≥ 3 × upper limit of normal values;
Other
- Pregnant women;
- Blood pressure below 90/60mmHg or above 180/100mmHg in the past 2 weeks;
- 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.);
- Combine the use of glucocorticoids and immunosuppressants, such as tacrolimus, cyclosporine, MMF, azathioprine, leflunomide, Tripterygium wilfordii glycosides, etc;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.