Far Infrared Therapy on Peritoneal Function of CAPD Patients

End-stage Renal Disease Clinical Trial

— CAPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04344067
• Other study ID #: 2015-09-002B
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Far Infrared Therapy
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.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Lin CC, Chang CF, Lai MY, Chen TW, Lee PC, Yang WC. Far-infrared therapy: a novel treatment to improve access blood flow and unassisted patency of arteriovenous fistula in hemodialysis patients. J Am Soc Nephrol. 2007 Mar;18(3):985-92. Epub 2007 Jan 31. — View Citation

Lin CC, Chung MY, Yang WC, Lin SJ, Lee PC. Length polymorphisms of heme oxygenase-1 determine the effect of far-infrared therapy on the function of arteriovenous fistula in hemodialysis patients: a novel physicogenomic study. Nephrol Dial Transplant. 2013 May;28(5):1284-93. doi: 10.1093/ndt/gfs608. Epub 2013 Jan 22. — View Citation

Lin CC, Liu XM, Peyton K, Wang H, Yang WC, Lin SJ, Durante W. Far infrared therapy inhibits vascular endothelial inflammation via the induction of heme oxygenase-1. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):739-45. doi: 10.1161/ATVBAHA.107.160085. Epub 2008 Jan 17. — View Citation

Lin CC, Yang WC, Chen MC, Liu WS, Yang CY, Lee PC. Effect of far infrared therapy on arteriovenous fistula maturation: an open-label randomized controlled trial. Am J Kidney Dis. 2013 Aug;62(2):304-11. doi: 10.1053/j.ajkd.2013.01.015. Epub 2013 Mar 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Weekly creatinine clearance	WCCr (L/wk/1.73m^2)	Change from baseline level at 6 months and 12 months
Secondary	Ultrafiltration volume	Peritoneal function parameter (mL)	Change from baseline level at 6 months and 12 months
Secondary	Net volume	Peritoneal function parameter (mL)	Change from baseline level at 6 months and 12 months
Secondary	D/D0 glucose ratio	Peritoneal function parameter	Change from baseline level at 6 months and 12 months
Secondary	D/PCr ratio	Peritoneal function parameter	Change from baseline level at 6 months and 12 months
Secondary	D/P urea ratio	Peritoneal function parameter	Change from baseline level at 6 months and 12 months
Secondary	Albumin	Biochemical function parameter (g/dL)	Change from baseline level at 6 months and 12 months
Secondary	Blood urea nitrogen	Biochemical function parameter (mg/dL)	Change from baseline level at 6 months and 12 months
Secondary	Creatinine	Biochemical function parameter (mg/dL)	Change from baseline level at 6 months and 12 months
Secondary	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
Secondary	Infection events (number of hospital admission events)	Pneumonia, peritonitis	Change from baseline level at 12 months