The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Location status: Recruiting
NCT Number: NCT06249373
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Suzhou, Jiangsu, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
Exclusion criteria
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.
Time frame: 12 weeks after enrollment
Puncture segment venous diameter
Time frame: 12 weeks after enrollment
Brachial artery blood flow rate
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Blood flow
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Minimum outflow venous diameter
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Primary patency rate
Time frame: 2 weeks,4weeks,8weeks,12weeks after enrollment, and 4 weeks after follow-up.
Secondary patency rate
Contact information is provided by the study sponsor or research team.
Suzhou Municipal Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07522008
Bronchial Diseases, Bronchiolitis
Cagliari, Italy
View Trial DetailsNCT07123909
Anemia Associated With End Stage Renal Disease, Bronchial Diseases
Moscow, Russia
View Trial DetailsNCT07033260
Bronchial Diseases, Bronchiolitis
Wuhu, Outside of the US, China
View Trial DetailsNCT07380113
Bronchial Diseases, Bronchiolitis
View Trial Details