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Trial registered on ANZCTR
Registration number
ACTRN12610000704099
Ethics application status
Approved
Date submitted
21/08/2010
Date registered
25/08/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Interactive Effect between Genetic Background of Heme Oxygenase-1 and Far Infrared Therapy on Arteriovenous (AV) Fistula Function in Hemodialysis Patients
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Scientific title
The Effect of Far Infrared Therapy on the Access Blood Flow and Unassisted Patency of Arteriovenous Fistula in Hemodialysis Patients: Interaction with Length Polymorphisms of Heme Oxygenase-1 (HO-1) Gene
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Secondary ID [1]
1034
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Cochrane Renal Group (CRG): CRG050600078
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Universal Trial Number (UTN)
nil
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Trial acronym
nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malfunction of AV fistula of hemodialysis (HD) patients
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Condition category
Condition code
Renal and Urogenital
258119
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0
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Other renal and urogenital disorders
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Alternative and Complementary Medicine
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
1. HD patients who are randomized into the treatment group will receive 40 minutes of far infrared therapy (FIR therapy) during hemodialysis three times per week for a year.
2. A Wide Spectrum (WS) TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) will be used for FIR therapy. Its generated wavelengths range between 3 and 25 microm (a peak between 5 and 6 microm). The top radiator will be set at a height of 25 cm above the surface of the AV fistula with the treatment time set at 40 minutes during HD thrice a week for a year.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
Patients in the control group will receive hemodialysis three times per week but without the use of far infrared therapy.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary end point was the survival time of the AV fistula with unassisted patency, which was defined as the time from the commencement of the study to the first episode of fistula malfunction. We defined AV fistula malfunction as the need for any interventional procedure (surgery or angioplasty) to correct an occlusive or malfunctioning fistula which can not sustain an extracorporeal blood flow greater than 200 ml/min during HD after excluding the following stenosis-unrelated events, such as infectious complication, progressive aneurysmal formation, or steal syndrome.
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Assessment method [1]
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Timepoint [1]
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12 months from randomisation
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Secondary outcome [1]
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Access blood flow: The access flow (Qa) was measured during HD by ultrasound dilution method using the Transonic hemodialysis monitor (HD02, Transonic Systems, Inc., Ithaca, New York). The technique uses two ultrasound sensors attached to the two HD tubing lines, one to the arterial and the other to the venous catheters, approximately 3 to 5 inches from the connection of the tubing to the dialysis needles. Initially, tubing lines are reversed, and ultrafiltration is turned off. A measured bolus of saline (10 ml) is injected into the venous catheter, resulting in changes in sound velocity that are measured by the transducers on the catheters. This change is then calculated by the Transonic software, giving the result of Qa (ml/min). If Qa could not be obtained by this method, it would be measured by the variable pump flow-based doppler ultrasound method.
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Assessment method [1]
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Timepoint [1]
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12 months from randomisation
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Eligibility
Key inclusion criteria
(1) receiving 4 hours of maintenance HD therapy three times weekly for at least 6 months at Taipei veterans general hospital, (2) using a native AV fistula as the present vascular access for more than 6 months, without interventions within the last 3 months, and (3) creation of AV fistula by similar surgical skills with end-to-side anastomosis at upper extremity.
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Minimum age
20
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) AV graft
(2) Life expectancy less than 12 months
(3) Central vein stenosis
(4) Factors affecting function of AV fistula, such as severe infection, severe aneurysmal dilatation leading to heart failure, etc.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After informed consent was obtained from every study subject, the patients were randomly allocated to either FIR group or to control group. The subject allocations was concealed from investigators and the allocation sequence was kept by a study nurse who would not tell the investigator the subject allocation until the time of intervention.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
by a computerized minimization algorithm to ensure balance between the two groups with respect to history of AV fistula malfunction.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
nil
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
2/05/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Taiwan, Province Of China
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State/province [1]
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Taiwan
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Taipei Veterans General Hospital
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Address [1]
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No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
Grant number :V95-ER2-003; V97C1-070; V98C1-045
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Country [1]
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Taiwan, Province Of China
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Funding source category [2]
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Government body
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Name [2]
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National Science Council
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Address [2]
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No. 106, Sec. 2, Ho-Ping East Rd, Taipei, 10622, Taiwan, Republic of China
Grant numbers: 106NSC95-2314-B-075-070; NSC96-2314-B-010-045; NSC97-2314-B-010-010-MY3
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Country [2]
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Taiwan, Province Of China
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Primary sponsor type
Hospital
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Name
Taipei Veterans General Hospital
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Address
No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
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Country
Taiwan, Province Of China
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Secondary sponsor category [1]
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Government body
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Name [1]
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National Science Council
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Address [1]
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No. 106, Sec. 2, Ho-Ping East Rd, Taipei, 10622, Taiwan, Republic of China
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Country [1]
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Taiwan, Province Of China
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Institutional Review Board Veterans General Hospital-Taipei
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Ethics committee address [1]
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No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
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Ethics committee country [1]
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Taiwan, Province Of China
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Date submitted for ethics approval [1]
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Approval date [1]
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02/05/2005
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Ethics approval number [1]
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VGHIRB No.: 94-05-07A
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Summary
Brief summary
Vascular access malfunction, usually presenting with an inadequate access flow (Qa), is the leading cause of morbidity and hospitalization in hemodialysis (HD) patients. A shorter length polymorphism with Guanine Thymine repeat number [(GT)n] >30 in the heme oxygenase-1 (HO-1) gene was associated with better prognosis of arteriovenous fistula (AVF) in hemodialysis (HD) patients. Many methods of thermal therapy have been tried for improving Qa but with limited effects. This randomized trial is designed to evaluate (1) the effect of far infrared therapy (FIR) on access flow and patency of the native arteriovenous fistula (AVF) and (2) the interaction between HO-1 length polymorphism and FIR therapy on access flow (Qa) and patency of arteriovenous fistula (AVF) in HD patients.
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Trial website
NIL
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Trial related presentations / publications
1. Chih-Ching Lin, Chao-Fu Chang, Hong-Jen Chiou, Ying-Chou Sun, Shou-Shan Chiang, Ming-Wei Lin, Pui-Ching Lee, Wu-Chang Yang. Variable Pump Flow-based Doppler Ultrasound Method: a Novel Approach to the Measurement of Access Flow in Hemodialysis Patients.
J Am Soc Nephrol 2005;16(1):229-36. SCI IF=7.371
2. Chih-Ching Lin, Wu-Chang Yang, Shing-Jong Lin, Tzen-Wen Chen, Wen-Shin Lee, Chao-Fu Chang, Pui-Ching Lee, Shou-Dong Lee, Ming-Yi Chung. Length Polymorphism in Heme Oxygenase-1 is Associated with Arteriovenous Fistula Patency in Hemodialysis Patients
Kidney Int 2006; 69:165–72. SCI IF = 6.4
3. Chih-Ching Lin, Chao-Fu Chang, Ming-Yu Lai, Tzen-Wen Chen, Pui-Ching Lee, Wu-Chang Yang. Far Infrared Therapy: a Novel Treatment Improving Access Blood Flow and Unassisted Patency of Arteriovenous Fistula in Hemodialysis Patients
J Am Soc Nephrol 2007; 18: 985-92.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr, Chih-Ching Lin
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Address
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Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
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Country
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Taiwan, Province Of China
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Phone
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+886-2-28712121-Ext. 2970
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Fax
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+886-2-28731582
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms, Hsiao-Ti Cheng
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Address
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6th Fl, Chung-Cheng Building, No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
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Country
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Taiwan, Province Of China
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Phone
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+886-2-28712121-Ext. 2061
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
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
2013
https://doi.org/10.1093/ndt/gfs608
N.B. These documents automatically identified may not have been verified by the study sponsor.
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