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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The WSTM TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) was used to conduct FIR therapy in this study. The electrified ceramic plates of the emitter generated electromagnetic waves with wavelengths in the range between 3 and 25 μm (a peak between 5 to 6 μm). The irradiating power density is 10 and 20 milliwatt (mw) /cm2 when the top radiator was set at a distance of 30 and 20 cm above the skin surface respectively.
Taipei Veterans General Hospital
Taipei, Taiwan
RECRUITINGKT/V
K - dialyzer urea clearance; t - dialysis time; V - total volume within the body that urea is distributed
Time frame: Change from baseline level at 6 months and 12 months
Weekly creatinine clearance
WCCr (L/wk/1.73m\^2)
Time frame: Change from baseline level at 6 months and 12 months
Ultrafiltration volume
Peritoneal function parameter (mL)
Time frame: Change from baseline level at 6 months and 12 months
Net volume
Peritoneal function parameter (mL)
Time frame: Change from baseline level at 6 months and 12 months
D/D0 glucose ratio
Peritoneal function parameter
Time frame: Change from baseline level at 6 months and 12 months
D/PCr ratio
Peritoneal function parameter
Time frame: Change from baseline level at 6 months and 12 months
D/P urea ratio
Peritoneal function parameter
Time frame: Change from baseline level at 6 months and 12 months
Albumin
Biochemical function parameter (g/dL)
Time frame: Change from baseline level at 6 months and 12 months
Blood urea nitrogen
Biochemical function parameter (mg/dL)
Time frame: Change from baseline level at 6 months and 12 months
Creatinine
Biochemical function parameter (mg/dL)
Time frame: Change from baseline level at 6 months and 12 months
Major cardiovascular adverse events
3-point major adverse cardiovascular events (3P-MACE) comprising of non-fatal stroke, myocardial infarction, and cardiovascular death, coronary artery disease (CAD), hospitalized heart failure (HHF)
Time frame: Change from baseline level at 12 months
Infection events (number of hospital admission events)
Pneumonia, peritonitis
Time frame: Change from baseline level at 12 months
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