Far Infrared Therapy on Peritoneal Function of CAPD Patients (CAPD)
Primary Purpose
End-stage Renal Disease
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Far Infrared Therapy
Sponsored by
About this trial
This is an interventional treatment trial for End-stage Renal Disease focused on measuring Peritoneal Dialysis, Far Infrared Therapy
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
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Far Infrared Therapy Group
Arm 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.
Outcomes
Primary Outcome Measures
KT/V
K - dialyzer urea clearance; t - dialysis time; V - total volume within the body that urea is distributed
Weekly creatinine clearance
WCCr (L/wk/1.73m^2)
Secondary Outcome Measures
Ultrafiltration volume
Peritoneal function parameter (mL)
Net volume
Peritoneal function parameter (mL)
D/D0 glucose ratio
Peritoneal function parameter
D/PCr ratio
Peritoneal function parameter
D/P urea ratio
Peritoneal function parameter
Albumin
Biochemical function parameter (g/dL)
Blood urea nitrogen
Biochemical function parameter (mg/dL)
Creatinine
Biochemical function parameter (mg/dL)
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)
Infection events (number of hospital admission events)
Pneumonia, peritonitis
Full Information
NCT ID
NCT04344067
First Posted
March 19, 2020
Last Updated
April 20, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04344067
Brief Title
Far Infrared Therapy on Peritoneal Function of CAPD Patients
Acronym
CAPD
Official Title
The Effect of Far Infrared Therapy on Peritoneal Function of CAPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
Peritoneal Dialysis, Far Infrared Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to either the control group or the treatment (far infrared therapy) group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Title
Far Infrared Therapy Group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Far Infrared Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
KT/V
Description
K - dialyzer urea clearance; t - dialysis time; V - total volume within the body that urea is distributed
Time Frame
Change from baseline level at 6 months and 12 months
Title
Weekly creatinine clearance
Description
WCCr (L/wk/1.73m^2)
Time Frame
Change from baseline level at 6 months and 12 months
Secondary Outcome Measure Information:
Title
Ultrafiltration volume
Description
Peritoneal function parameter (mL)
Time Frame
Change from baseline level at 6 months and 12 months
Title
Net volume
Description
Peritoneal function parameter (mL)
Time Frame
Change from baseline level at 6 months and 12 months
Title
D/D0 glucose ratio
Description
Peritoneal function parameter
Time Frame
Change from baseline level at 6 months and 12 months
Title
D/PCr ratio
Description
Peritoneal function parameter
Time Frame
Change from baseline level at 6 months and 12 months
Title
D/P urea ratio
Description
Peritoneal function parameter
Time Frame
Change from baseline level at 6 months and 12 months
Title
Albumin
Description
Biochemical function parameter (g/dL)
Time Frame
Change from baseline level at 6 months and 12 months
Title
Blood urea nitrogen
Description
Biochemical function parameter (mg/dL)
Time Frame
Change from baseline level at 6 months and 12 months
Title
Creatinine
Description
Biochemical function parameter (mg/dL)
Time Frame
Change from baseline level at 6 months and 12 months
Title
Major cardiovascular adverse events
Description
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)
Time Frame
Change from baseline level at 12 months
Title
Infection events (number of hospital admission events)
Description
Pneumonia, peritonitis
Time Frame
Change from baseline level at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Ching Lin, MD, PhD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih-Ching Lin, MD, PhD
Phone
02-2871-2121
Ext
2993
Email
lincc2@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Chih-Ching Lin, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17267744
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.
Results Reference
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PubMed Identifier
18202320
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.
Results Reference
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PubMed Identifier
23474008
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.
Results Reference
background
PubMed Identifier
23345623
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.
Results Reference
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Far Infrared Therapy on Peritoneal Function of CAPD Patients
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