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

Zhejiang University

Status: Unknown

Conditions: Renal Transplantation; Renal Insufficiency

Treatments: Device: ultrasonic therapeutic apparatus 1; Device: ultrasonic therapeutic apparatus 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04119427

2019-194

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Test Group

Experimental group

Description:

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.

Treatment:

Device: ultrasonic therapeutic apparatus 1

Control Group

Placebo Comparator group

Description:

The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Treatment:

Device: ultrasonic therapeutic apparatus 2