The Interactive Effect between Genetic Background of Heme Oxygenase-1 and Far Infrared Therapy on Arteriovenous (AV) Fistula Function in Hemodialysis Patients
Phase 4
Active, not recruiting
- Conditions
- Malfunction of AV fistula of hemodialysis (HD) patientsRenal and Urogenital - Other renal and urogenital disordersAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12610000704099
- Lead Sponsor
- Taipei Veterans General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 300
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[12 months from randomisation]
- Secondary Outcome Measures
Name Time Method 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.[12 months from randomisation]