The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation: A Multicenter, Randomized Clinical Trail
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Measuring the patient'serum creatinine by a biochemical analyzer
研究概览
简要总结
The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ultrasonic therapeutic apparatus 1 (Device)
Control Group
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
干预措施: ultrasonic therapeutic apparatus 2 (Device)
结局指标
主要结局
Measuring the patient'serum creatinine by a biochemical analyzer
时间窗: 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
时间窗: 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
时间窗: within 3 months after surgery
Measuring the patient'urea nitrogen by a biochemical analyzer
次要结局
- Monitoring the blood flow of the transplanted kidney by a doppler ultrasound(within 3 months after surgery)