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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01138254
First received: May 25, 2010
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Device: WSTM TY101 FIR emitter (Far infrared therapy)
Other: no intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Plasma asymmetric dimethyl arginine (ADMA) and L-arginine [ Time Frame: 6 months (every 3 months) ] [ Designated as safety issue: No ]
    Plasma L-arginine and ADMA concentrations were determined by HPLC using precolumn derivatization with o-phthaldialdehyde (OPA) at 0 (before creation of AVF), 3rd and 6th months after creation of AV fistula.


Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
ESRD patients will not receive FIR therapy in this study.
Other: no intervention
no intervention
Other Name: no intervention by FIR therapy
Experimental: Far infrared therapy
Patients will receive far infrared therapy 40 minutes three times weekly (TIW) for 6 months.
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 Name: Far infrared therapy (WSTM TY101 FIR emitter)

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  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138254

Contacts
Contact: Hsiao-Di Cheng, BSc +886-2-28712121 ext 2061 p20039@hotmail.com

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: CHIH-CHING LIN, MD, PhD    +886-2-28712121 ext 2970    lincc2@vghtpe.gov.tw   
Principal Investigator: CHIH-CHING LIN, MD;PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: CHIH-CHING LIN, MD, PhD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided by Taipei Veterans General Hospital, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHIH-CHING LIN, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01138254     History of Changes
Other Study ID Numbers: V98C1-045
Study First Received: May 25, 2010
Last Updated: July 12, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital, Taiwan:
flow,echocardiography,far infrared therapy,nitric oxide

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014