Trial Review

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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
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
Secondary ID [1] 1034 0
Cochrane Renal Group (CRG): CRG050600078
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malfunction of AV fistula of hemodialysis (HD) patients 243750 0
Condition category
Condition code
Renal and Urogenital 258119 258119 0 0
Other renal and urogenital disorders
Alternative and Complementary Medicine 258186 258186 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257061 0
Treatment: Devices
Comparator / control treatment
Patients in the control group will receive hemodialysis three times per week but without the use of far infrared therapy.
Control group
Active

Outcomes
Primary outcome [1] 240818 0
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.
Timepoint [1] 240818 0
12 months from randomisation
Secondary outcome [1] 257488 0
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.
Timepoint [1] 257488 0
12 months from randomisation

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.
Minimum age
20 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2072 0
Taiwan, Province Of China
State/province [1] 2072 0
Taiwan

Funding & Sponsors
Funding source category [1] 243653 0
Hospital
Name [1] 243653 0
Taipei Veterans General Hospital
Country [1] 243653 0
Taiwan, Province Of China
Funding source category [2] 257506 0
Government body
Name [2] 257506 0
National Science Council
Country [2] 257506 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Taipei Veterans General Hospital
Address
No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
Country
Taiwan, Province Of China
Secondary sponsor category [1] 256742 0
Government body
Name [1] 256742 0
National Science Council
Address [1] 256742 0
No. 106, Sec. 2, Ho-Ping East Rd, Taipei, 10622, Taiwan, Republic of China
Country [1] 256742 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259533 0
Institutional Review Board Veterans General Hospital-Taipei
Ethics committee address [1] 259533 0
No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
Ethics committee country [1] 259533 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 259533 0
Approval date [1] 259533 0
02/05/2005
Ethics approval number [1] 259533 0
VGHIRB No.: 94-05-07A

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.
Trial website
NIL
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.
Public notes

Contacts
Principal investigator
Name 30203 0
Address 30203 0
Country 30203 0
Phone 30203 0
Fax 30203 0
Email 30203 0
Contact person for public queries
Name 13450 0
Dr, Chih-Ching Lin
Address 13450 0
Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
Country 13450 0
Taiwan, Province Of China
Phone 13450 0
+886-2-28712121-Ext. 2970
Fax 13450 0
+886-2-28731582
Email 13450 0
lincc2@vghtpe.gov.tw
Contact person for scientific queries
Name 4378 0
Ms, Hsiao-Ti Cheng
Address 4378 0
6th Fl, Chung-Cheng Building, No. 201, Sec. 2, Shih-Pai Road, Taipei, Taiwan 112, Republic of China
Country 4378 0
Taiwan, Province Of China
Phone 4378 0
+886-2-28712121-Ext. 2061
Fax 4378 0
Email 4378 0
p20039@hotmail.com

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
SourceTitleYear of PublicationDOI
Dimensions AILength polymorphisms of heme oxygenase-1 determine the effect of far-infrared therapy on the function of arteriovenous fistula in hemodialysis patients: a novel physicogenomic study2013https://doi.org/10.1093/ndt/gfs608
N.B. These documents automatically identified may not have been verified by the study sponsor.