The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF

Launched by SUZHOU MUNICIPAL HOSPITAL · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how low-intensity pulse ultrasound (LIPUS) might help improve the growth and function of newly created arteriovenous fistulas (AVFs) in patients with chronic kidney disease. An AVF is a connection made between an artery and a vein to help with dialysis treatment. The trial will last 12 weeks and includes two stages: the first stage is a smaller study to test the concept, while the second stage will take place at multiple centers to gather more data. Participants will be divided into two groups—one receiving the ultrasound treatment and the other not receiving it—so researchers can compare the outcomes.

To be eligible, participants must be between 18 and 75 years old, have a newly constructed AVF in their wrist that hasn't been used for dialysis yet, and meet certain health criteria. Patients with active infections, poor healing from surgery, or other serious health issues may not qualify. Throughout the study, participants will have regular check-ups to ensure their safety and to see how well the AVFs are maturing. This trial is currently recruiting participants, and those interested should consult their healthcare provider for more information.

Gender

ALL

Eligibility 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 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.