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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis
  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 2

Первичные конечные точки

• Maturity rate of arteriovenous fistula [Срок оценки: 12 weeks after enrollment]
• Maturity rate of arteriovenous fistula [Срок оценки: 12 weeks after enrollment]

Вторичные конечные точки (4)

• Changes in hemodynamic parameters [Срок оценки: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.]
• Changes in hemodynamic parameters [Срок оценки: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.]
• Changes in hemodynamic parameters [Срок оценки: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.]
• Changes in hemodynamic parameters [Срок оценки: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital — Сучжоу

Публикации

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• Salmela B, Hartman J, Peltonen S, Alback A, Lassila R. Thrombophilia and arteriovenous fistula survival in ESRD. Clin J Am Soc Nephrol. 2013 Jun;8(6):962-8. doi: 10.2215/CJN.03860412. Epub 2013 Feb 14. PMID 23411429
• Sifuentes-Franco S, Padilla-Tejeda DE, Carrillo-Ibarra S, Miranda-Diaz AG. Oxidative Stress, Apoptosis, and Mitochondrial Function in Diabetic Nephropathy. Int J Endocrinol. 2018 Apr 1;2018:1875870. doi: 10.1155/2018/1875870. eCollection 2018. PMID 29808088
• Masengu A, McDaid J, Maxwell AP, Hanko JB. Preoperative radial artery volume flow is predictive of arteriovenous fistula outcomes. J Vasc Surg. 2016 Feb;63(2):429-35. doi: 10.1016/j.jvs.2015.08.106. PMID 26804217
• Riella MC, Roy-Chaudhury P. Vascular access in haemodialysis: strengthening the Achilles' heel. Nat Rev Nephrol. 2013 Jun;9(6):348-57. doi: 10.1038/nrneph.2013.76. Epub 2013 Apr 16. PMID 23591442
• Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30. PMID 24183112
• Dember LM, Beck GJ, Allon M, Delmez JA, Dixon BS, Greenberg A, Himmelfarb J, Vazquez MA, Gassman JJ, Greene T, Radeva MK, Braden GL, Ikizler TA, Rocco MV, Davidson IJ, Kaufman JS, Meyers CM, Kusek JW, Feldman HI; Dialysis Access Consortium Study Group. Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA. 2008 May 14;299(18):2164-71 PMID 18477783
• Irish AB, Viecelli AK, Hawley CM, Hooi LS, Pascoe EM, Paul-Brent PA, Badve SV, Mori TA, Cass A, Kerr PG, Voss D, Ong LM, Polkinghorne KR; Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) Study Collaborative Group. Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Cl PMID 28055065

Идентификаторы

NCT: NCT06249373 · K-2023-094

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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