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Far Infrared Therapy on AV Fistula Flow, Endothelial Function and Echocardiography in ESRD Patients

NCT01138254 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-07-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

WSTM TY101 FIR emitter (Far infrared therapy)

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.

OTHER

no intervention

no intervention

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • CHIH-CHING LIN, MD, PhD · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138254 on ClinicalTrials.gov