Far Infrared Therapy on AV Fistula Flow, Endothelial Function and Echocardiography in ESRD Patients
The Effect of Far Infrared (FIR) Therapy on Access Flow of Arteriovenous (AV) Fistula, Echocardiographic Parameters and Endothelial Function in Patients With End Stage Renal Disease
1 other identifier
interventional
200
1 country
1
Brief Summary
Vascular access complications are the leading cause of morbidity in hemodialysis (HD) patients, and are responsible for a significant percentage of hospitalization, with annual costs approaching one billion dollars in the United States. Thrombosis is the most common cause of vascular access failure, and usually develops from stenotic lesions in the venous outflow tract. It has been reported that far infrared (FIR) therapy can improve access flow and unassisted patency of AV fistula, however, the effect of FIR on cardiac function is unknown. The aims of this study are to evaluate (1) the change of access flow of AV fistula and the effect of AV fistula on echocardiographic parameters and (2) the effect of FIR on access flow of AVF and echocardiographic parameters and the serum levels of endothelial markers in patients with end stage renal disease (ESRD) during the first 6 months after the creation of AV fistula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
June 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJuly 14, 2011
July 1, 2011
2.7 years
May 25, 2010
July 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Access flow monthly for 3 months and 6th month (0,1st,2nd,3rd and 6th months) and Echocardiographic parameters at 6th month ( 0 and 6th months)
Color Doppler ultrasonography was carried out to measure the access flow of AV fistula with commercially available equipment (Model SSA 340A; Toshiba, Tokyo, Japan). Echocardiographic parameters will be analysed according to the American Society of Echocardiography criteria with a Sonos 5500 sonographic system (Philips, Andover, MA, USA) incorporated with a multi-frequency transducer.Left atrial dimension was determined by M-mode echocardiography.
6 months
Secondary Outcomes (1)
Plasma asymmetric dimethyl arginine (ADMA) and L-arginine
6 months (every 3 months)
Study Arms (2)
control group
NO INTERVENTIONESRD patients will not receive FIR therapy in this study.
Far infrared therapy
EXPERIMENTALPatients will receive far infrared therapy 40 minutes three times weekly (TIW) for 6 months.
Interventions
A WSTM TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) will be used for FIR therapy. The electrified ceramic plates of this emitter generate 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 mili watt\<mw\>/cm2 when the top radiator is set at a distance between 30 and 20 cm above the skin surface respectively. In this study, the top radiator will be set at a height of 25 cm above the surface of bilateral lower legs and the treatment time will be set at 40 minutes three times weekly (TIW) for ESRD patients for 6 months.
Eligibility Criteria
You may qualify if:
- (1) age between 18 and 80,
- (2) chronic kidney disease (CKD) stage 5 with clearance of creatinine (CCr) less than 15 ml/min,
- (3) not receiving dialysis or renal transplantation,
- (4) is going to receive creation of AV fistula with the standardized surgical procedures of venous end-to-arterial side anastomosis in the upper extremity.
You may not qualify if:
- (1) creation of AV graft or Perm catheter as the type of vascular access,
- (2) heart failure in NYHA Fc III or IV,
- (3) episode of unstable angina, myocardial infarction, cerebrovascular event or receiving percutaneous coronary intervention therapy (PCI; including angioplasty or placement of stent ) within 3 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veterans General Hospital
Taipei, Taiwan, 112, Taiwan
Related Publications (1)
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.
PMID: 23474008DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CHIH-CHING LIN, MD, PhD
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 25, 2010
First Posted
June 7, 2010
Study Start
November 1, 2008
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
July 14, 2011
Record last verified: 2011-07