Far Infrared Therapy on Peritoneal Function of CAPD Patients

Phase 3

• Conditions: End-stage Renal Disease
• Interventions: Device: Far Infrared Therapy

• Registration Number: NCT04344067
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

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 Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2020-03-19
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-14
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-22
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Far Infrared Therapy Group	Far Infrared Therapy	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.

Primary Outcome Measures

Name	Time	Method
Weekly creatinine clearance	Change from baseline level at 6 months and 12 months	WCCr (L/wk/1.73m\^2)
KT/V	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan