The Effect of Far Infrared Therapy on Peritoneal Function of CAPD Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weekly creatinine clearance
研究概览
简要总结
For patients with end-stage renal disease, peritoneal dialysis (PD) has been proven to be an alternative choice compared to hemodialysis as a type of maintenance renal replacement therapy. Despite this, long-term PD is associated with structural membrane changes that are believed to contribute to alterations in solute transport and loss of ultrafiltration. Previous studies have proven that far-infrared (FIR) therapy may improve not only the arteriovenous fistula patency in hemodialysis patients but also abdominal discomfort due to encapsulating peritoneal sclerosis in PD patients. Since there is little information concerning this issue, this study was conducted in order to evaluate the possible effects of FIR therapy on the peritoneal function of patients receiving continuous ambulatory peritoneal dialysis (CAPD). The objective of this study is to evaluate the effect of FIR therapy on the peritoneal function, protein loss, and ultrafiltration capacity of CAPD patients.
详细描述
A total of 100 CAPD patients will be enrolled in this study, including 50 in treatment group who will receive FIR therapy for 6 months and 50 in control group. Many parameters of blood and urine samples as well as ultrafiltration amount, dialysate urea nitrogen, creatinine, Na+, K+, total protein, CA-125, and glucose degradation product (GDP) for the dialysate effluent of not only the first and last exchanges but also the total exchanges of daily PD regimen will be measured for both groups at day 1 and 6th month. However, only the FIR group will receive tests of blood, urine and dialysate on day 2. The significance of the study is that patients might benefit from the prophylactic therapeutic effects of FIR therapy, leading to the reduction of the hospitalization costs and the need for interventional procedures in CAPD patient care in Taiwan.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic peritoneal dialysis patients who have not received any FIR therapy within the previous 12 months
- •Patients on a standard continuous ambulatory peritoneal dialysis (CAPD) (1.5-2 L; 4-5 exchanges/day) or ambulatory peritoneal dialysis (APD) program
排除标准
- •History of CAPD-related peritonitis within 3 months prior to the study period;
- •History of cerebrovascular accident or myocardial infarction or interventional procedure (percutaneous transluminal coronary angioplasty or stent) for coronary artery disease within the 3 months prior to the study
结局指标
主要结局
Weekly creatinine clearance
时间窗: Change from baseline level at 6 months and 12 months
WCCr (L/wk/1.73m\^2)
KT/V
时间窗: Change from baseline level at 6 months and 12 months
K - dialyzer urea clearance; t - dialysis time; V - total volume within the body that urea is distributed
次要结局
- Net volume(Change from baseline level at 6 months and 12 months)
- Ultrafiltration volume(Change from baseline level at 6 months and 12 months)
- Albumin(Change from baseline level at 6 months and 12 months)
- D/PCr ratio(Change from baseline level at 6 months and 12 months)
- D/P urea ratio(Change from baseline level at 6 months and 12 months)
- Infection events (number of hospital admission events)(Change from baseline level at 12 months)
- D/D0 glucose ratio(Change from baseline level at 6 months and 12 months)
- Blood urea nitrogen(Change from baseline level at 6 months and 12 months)
- Creatinine(Change from baseline level at 6 months and 12 months)
- Major cardiovascular adverse events(Change from baseline level at 12 months)