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

NCT06249373 | Recruiting DMC

• 1 other identifier: K-2023-094
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Uremia; Chronic

Outcome Measures

Primary Outcomes (2)

• Maturity rate of arteriovenous fistula

  Puncture segment venous diameter

  12 weeks after enrollment

• Maturity rate of arteriovenous fistula

  Brachial artery blood flow rate

  12 weeks after enrollment

Secondary Outcomes (4)

• Changes in hemodynamic parameters

  2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.

• Changes in hemodynamic parameters

  2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.

• Changes in hemodynamic parameters

  2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.

• Changes in hemodynamic parameters

  2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.

Study Arms (2)

LIPUS intervention group

EXPERIMENTAL

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 tract, it also intervenes at the narrow site. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.

Device: Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis

Simulated LIPUS control group

NO INTERVENTION

Using the same forearm wearable portable ultrasound as the LIPUS arteriovenous fistula intervention group, but not issuing low-intensity pulse ultrasound.

Interventions

Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis DEVICE

The LIPUS intervention group for arteriovenous fistula should receive forearm wearable portable low-intensity pulse ultrasound （LIPUS） intervention at the anastomotic site no more than 3 days after suture removal two weeks after the fistula surgery. If the ultrasound examination indicates the presence of stenosis in the outflow tract, the intervention should also be performed at the same time. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.

LIPUS intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ Age ≤ 75 years old, regardless of gender or ethnicity;
• 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;
• 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;
• \. 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;
• \. Sign an informed consent form.

You may not qualify if:

• Poor healing of internal fistula surgical incision;
• Active bacterial or viral infections;
• Pregnant women;
• The patient underwent kidney transplantation or was transferred to peritoneal dialysis during the study period;
• Subject ALT, AST ≥ 3 × upper limit of normal values;
• 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;
• 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;
• Other researchers consider inappropriate situations, such as coexisting with malignant tumors, where the expected lifespan is less than 6 months;
• I have participated in other clinical trials within 4 weeks prior to the start of this study.

Sponsors & Collaborators

• Suzhou Municipal Hospital: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Dushu Lake Hospital Affiliated to Soochow University: collaborator

Study Sites (1)

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

Suzhou, Jiangsu, China

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Uremia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Xiangqing Kong

  Suzhou Municipal Hospital

  STUDY CHAIR

• Huijuan Mao

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Qiang Chen

CONTACT

+8618901547679; chenqjs@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nephrology

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 8, 2024
• Study Start: February 26, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)