The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation

Study Overview
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Brief Summary
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The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.

Detailed Description
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Study purposes: To evaluate the safety and efficacy of micro-energy ultrasound in the treatment of renal dysfunction after renal transplantation by measuring serum creatinine, urine volume, urea nitrogen, and transplanted kidney ultrasound, etc. Study design: This is a randomized, double-blind, controlled, multicenter clinical trial. Study objects: Patients with mild to moderate renal insufficiency after renal transplantation. Number of samples: 90 Main study center: Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. Treatments: Test group: After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed.Patients were treated twice a week for 6 weeks. Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Official Title
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The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation: A Multicenter, Randomized Clinical Trail

Conditions
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Renal Insufficiency, Renal Transplantation

Intervention / Treatment
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* Device: ultrasonic therapeutic apparatus 1
* Device: ultrasonic therapeutic apparatus 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than half a year after renal transplantation, serum creatinine elevated over three times , patients with ineffective immunosuppressive drugs; Mild to moderate renal insufficiency (creatinine less than 442umol / L); Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign the informed consent form. Exclusion Criteria: Patients with severe renal insufficiency; Blood routine suggests acute and chronic blood system diseases; B-ultrasound suggests transplanting hydronephrosis; Uncontrollable patients with diabetes, hypertension, and cardiovascular disease; The investigator determined that it is not suitable for this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks. | Device: ultrasonic therapeutic apparatus 1<br>* After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.<br>|
| Placebo Comparator: Control Group<br>The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. | Device: ultrasonic therapeutic apparatus 2<br>* The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the patient'serum creatinine by a biochemical analyzer | Measuring the patient'serum creatinine by a biochemical analyzer | within 3 months after surgery | 
| Manually record the patient's urine volume in 24 hours by a measuring glass | Manually record the patient's urine volume in 24 hours by a measuring glass | within 3 months after surgery | 
| Measuring the patient'urea nitrogen by a biochemical analyzer | Measuring the patient'urea nitrogen by a biochemical analyzer | within 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring the blood flow of the transplanted kidney by a doppler ultrasound | Monitoring the blood flow of the transplanted kidney by a doppler ultrasound | within 3 months after surgery |