Renal Insufficiency, Renal Transplantation
Conditions
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.
Interventions
DEVICEultrasonic therapeutic apparatus 1
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.
DEVICEultrasonic therapeutic apparatus 2
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring the patient'serum creatinine by a biochemical analyzer | within 3 months after surgery | Measuring the patient'serum creatinine by a biochemical analyzer |
| Manually record the patient's urine volume in 24 hours by a measuring glass | within 3 months after surgery | Manually record the patient's urine volume in 24 hours by a measuring glass |
| Measuring the patient'urea nitrogen by a biochemical analyzer | within 3 months after surgery | Measuring the patient'urea nitrogen by a biochemical analyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring the blood flow of the transplanted kidney by a doppler ultrasound | within 3 months after surgery | Monitoring the blood flow of the transplanted kidney by a doppler ultrasound |
Countries
China
Contacts
Primary ContactJiaquan Xiao, Dr.
Outcome results
None listed