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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080337
Enrollment
Unknown
Registered
2024-01-26
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremia

Interventions

Step1: LIPUS intervention group:Low intensity pulse ultrasound (LIPUS) intervenes at the anastomotic site, and if the ultrasound examination indicates the presence of a narrow site in the outflow trac
Step1: Simulated LIPUS control group:Using the same forearm wearable portable ultrasound as the LIPUS arteriovenous fistula intervention group, but not issuing low-intensity pulse ultrasound.
Step2: LIPUS intervention group:Low intensity pulse ultrasound (LIPUS) intervenes at the anastomotic site, and if the ultrasound examination indicates the presence of a narrow site in the outflow trac
Step2: Simulated LIPUS control group:Using the same forearm wearable portable ultrasound as the LIPUS arteriovenous fistula intervention group, but not issuing low-intensity pulse ultrasound.

Sponsors

The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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 was performed. The radial artery diameter at the intended surgical site was>1.5mm, and the head vein diameter was>2mm (using a tourniquet). The arterial and venous blood flow was unobstructed, and the distance between the vein and the skin was<6mm; 4. After introducing dialysis, the calcium ion concentration in the dialysate was maintained at 1.5mmol/L during the dialysis period, and low molecular weight heparin was used for anticoagulation. The dosage of low molecular weight heparin remained unchanged (± 1000U) during the study period; 5. Sign an informed consent form.

Exclusion criteria

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, Agatroban, 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

MeasureTime frame
Maturity rate of arteriovenous fistula;

Secondary

MeasureTime frame
Changes in hemodynamic parameters (blood flow, minimum outflow venous diameter), primary patency rate, secondary patency rate.;

Countries

China

Contacts

Public ContactXiangqing Kong

The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital

kongxq@njmu.edu.cn+86 139 5161 0265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026