Clinical trial NCT04344067: Far Infrared Therapy on Peritoneal Function of CAPD Patients
Official title: The Effect of Far Infrared Therapy on Peritoneal Function of CAPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: End-stage Renal Disease
Keywords: Peritoneal Dialysis
Far Infrared Therapy
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either the control group or the treatment (far infrared therapy) group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: KT/V
timeFrame: Change from baseline level at 6 months and 12 months
measure: Weekly creatinine clearance
timeFrame: Change from baseline level at 6 months and 12 months
Secondary outcomes:
measure: Ultrafiltration volume
timeFrame: Change from baseline level at 6 months and 12 months
measure: Net volume
timeFrame: Change from baseline level at 6 months and 12 months
measure: D/D0 glucose ratio
timeFrame: Change from baseline level at 6 months and 12 months
measure: D/PCr ratio
timeFrame: Change from baseline level at 6 months and 12 months
measure: D/P urea ratio
timeFrame: Change from baseline level at 6 months and 12 months
measure: Albumin
timeFrame: Change from baseline level at 6 months and 12 months
measure: Blood urea nitrogen
timeFrame: Change from baseline level at 6 months and 12 months
measure: Creatinine
timeFrame: Change from baseline level at 6 months and 12 months
measure: Major cardiovascular adverse events
timeFrame: Change from baseline level at 12 months
measure: Infection events (number of hospital admission events)
timeFrame: Change from baseline level at 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chih-Ching Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1681/ASN.2006050534. Epub 2007 Jan 31.
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.
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.
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.