Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients (NCT04011072) | Clinical Trial Compass
CompletedNot Applicable
Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients
Denmark206 participantsStarted 2019-10-03
Plain-language summary
The number of hemodialysis patients in the world are increasing. In order to receive a sufficient dialysis, the patients needs a well functioning and stable vascular access - preferably an arteriovenous fistula (AVF). Unfortunately, the AVF has a high incidence of stenosis with percutaneous trans luminal angioplasty (PTA) as the only treatment option and a short lifetime. Little do we know of how to improve the survival of the AVF.
With this study we want to explore the effect of far infrared therapy on the stenosis, maturation and survival of the arteriovenous fistula.
The investigators will divide the patients into 2 groups: A treatment group and a control group.
The treatment group will receive infrared therapy on their fistula during their dialysis session. The control group will not receive any infrared therapy.
The investigators hope to reduce the risk of stenosis in the fistula and improve the fistula survival with this treatment.
Furthermore, the investigators want to explore the change in several biochemical markers during the treatment with infrared therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For incident AVF:
* Patients of 18 years of age or above
* Patients on chronic hemodialysis with a central venous catheter, who is having an AVF placed
* An AVF, that are maximum 3 weeks old
For prevalent AVF:
* Patients in chronic hemodialysis with a functioning AVF
* Patients of 18 yeas of age or above
Exclusion Criteria:
* Not obtainable informed consent
* Non compliant patients
* Patients who use both a CVC and an AVF as their vascular access
* Patient on both hemodialysis and peritoneal dialysis
* Planned living donor kidney transplantation
* Short life expectancy, less than a 1 year
* Patients on hemodialysis less than 3 times per week
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to fistula maturation for the incident fistulae
Timeframe: After 12 months
2
Difference in number of fistula intervention for the prevalent fistulae