Clinical trial NCT04119427: The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation
Official title: The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation: A Multicenter, Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency
Renal Transplantation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: First Affiliated Hospital of Wenzhou Medical University
First posted: 2019-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.

Detailed description: 1. 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.
2. Study design: This is a randomized, double-blind, controlled, multicenter clinical trial.
3. Study objects: Patients with mild to moderate renal insufficiency after renal transplantation.
4. Number of samples: 90
5. Main study center: Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
6. 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.

Eligibility criteria: Inclusion Criteria:

1. More than half a year after renal transplantation, serum creatinine elevated over three times , patients with ineffective immunosuppressive drugs;
2. Mild to moderate renal insufficiency (creatinine less than 442umol / L);
3. Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe renal insufficiency;
2. Blood routine suggests acute and chronic blood system diseases;
3. B-ultrasound suggests transplanting hydronephrosis;
4. Uncontrollable patients with diabetes, hypertension, and cardiovascular disease;
5. The investigator determined that it is not suitable for this clinical trial.

Primary outcomes:
measure: Measuring the patient'serum creatinine by a biochemical analyzer
timeFrame: within 3 months after surgery
measure: Manually record the patient's urine volume in 24 hours by a measuring glass
timeFrame: within 3 months after surgery
measure: Measuring the patient'urea nitrogen by a biochemical analyzer
timeFrame: within 3 months after surgery
Secondary outcomes:
measure: Monitoring the blood flow of the transplanted kidney by a doppler ultrasound
timeFrame: within 3 months after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: