Far Infrared Therapy on Peritoneal Function of CAPD Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Far Infrared Therapy on Peritoneal Function of CAPD Patients

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Device: Far Infrared Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to either the control group or the treatment (far infrared therapy) group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br> | |
| Experimental: Far Infrared Therapy Group<br>In this study, the top radiator of the far infrared emitter was set at a height of 25 cm above the umbilicus with a treatment time of 40 minutes during the initial 1 hour of both the first daily and the last night-time indwelling dialysate of each daily regular peritoneal dialysis regimen. | Device: Far Infrared Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KT/V | K - dialyzer urea clearance; t - dialysis time; V - total volume within the body that urea is distributed | Change from baseline level at 6 months and 12 months | 
| Weekly creatinine clearance | WCCr (L/wk/1.73m^2) | Change from baseline level at 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrafiltration volume | Peritoneal function parameter (mL) | Change from baseline level at 6 months and 12 months | 
| Net volume | Peritoneal function parameter (mL) | Change from baseline level at 6 months and 12 months | 
| D/D0 glucose ratio | Peritoneal function parameter | Change from baseline level at 6 months and 12 months | 
| D/PCr ratio | Peritoneal function parameter | Change from baseline level at 6 months and 12 months | 
| D/P urea ratio | Peritoneal function parameter | Change from baseline level at 6 months and 12 months | 
| Albumin | Biochemical function parameter (g/dL) | Change from baseline level at 6 months and 12 months | 
| Blood urea nitrogen | Biochemical function parameter (mg/dL) | Change from baseline level at 6 months and 12 months | 
| Creatinine | Biochemical function parameter (mg/dL) | 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) | Change from baseline level at 12 months | 
| Infection events (number of hospital admission events) | Pneumonia, peritonitis | Change from baseline level at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Dialysis, Far Infrared Therapy