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New treatment option for Uremia; Chronic
Official title The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
ClinicalTrials.gov ID: NCT06249373
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 3.Before establishing an autologous arteriovenous fistula in the wrist, ultrasound examination will be performed. The radial artery diameter at the...
- 4\. After introducing dialysis, the calcium ion concentration in the dialysate will be maintained at 1.5mmol/L during the dialysis period, and low...
- 5\. Sign an informed consent form.
You likely can't join 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;
See the full eligibility 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...
- 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...
- 5\. Sign an informed consent form.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.