Far Infrared Therapy on Peritoneal Function of CAPD Patients

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 3

Conditions: End-stage Renal Disease

Treatments: Device: Far Infrared Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04344067

2015-09-002B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control Group

No Intervention group

Far Infrared Therapy Group

Experimental group

Description:

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.

Treatment:

Device: Far Infrared Therapy