Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT04011072|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Arterio-venous Fistula||Radiation: Far infrared radiation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||187 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Far Infrared Therapy on Arteriovenous Fistulas Maturation, Survival and Stenosis. A Randomized, Controlled Open-labeled Multicenter Study|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2024|
Active Comparator: Infrared treatment arm
Far infrared radiation will be given for 40 minutes on the skin above the patients fistula in each dialysis session for one year
Radiation: Far infrared radiation
The treatment group will receive FIR for 40 minutes on the skin above the fistula during each dialysis session for one year.
Other Name: FIR
No Intervention: Control arm
The control group will not receive any intervention, but will be followed with the same data as the treatment group
- Time to fistula maturation for the incident fistulae [ Time Frame: After 12 months ]Time from placement of the fistula to successful cannulation with 2 needles and successful hemodialysis treatment
- Difference in number of fistula intervention for the prevalent fistulae [ Time Frame: After 12 months ]For the fistulae with or without previous interventions we expect to find a decrease in the number of interventions in the treatment group compared to the control group
- Difference in number of fistula interventions in the incident fistula group [ Time Frame: After 12 months ]Difference in the number of fistula intervention in the groups with a newly places fistula
- Difference in the fistula diameter in the incident fistula group [ Time Frame: After 12 months ]Is there a difference in the diameter measured by ultrasound between the 2 groups with patients with a newly places fistula
- Number of abandoned fistulae in incident and prevalent groups [ Time Frame: After 12 months ]For patients with a new fistula and patients with a fistula with/without interventions how many will loose their fistula and receive a new vascular access
- The incidence of primary patency in the incident group [ Time Frame: After 12 months ]How many of the fistulas in the group with a new fistula needs an intervention in order to get a functioning fistula
- Number of patients with a never functioning fistula in the incident group [ Time Frame: After 12 months ]How many patients in the newly places fistula group will never have a functioning fistula
- Change in access flow in the incident and prevalent group [ Time Frame: After 12 moths ]Does the access flow change between the control and treatment group
- Anti-inflammatory and vasodilating markers as a predictor for AVF survival and stenosis [ Time Frame: After 12 months ]Before study start collection of a blood sample for all patients. Analysing SAA, VCAM, ICAM, sE-selectin, vWF, nitrite, nitrate, ADMA, HO-1, endothelin, PGE2, IL-beta, IL6, IL8, TNF-alpha, TGF-beta and MCP as biomarkers for AVF survival and stenosis
- Difference in cannulation pain in the incident and prevalent group [ Time Frame: After 12 months ]Do the patients receiving FIR treatment experience less pain during cannulation compared to the control group
- Difference in number with steal symptoms in the incident and prevalent group [ Time Frame: After 12 months ]Is there a difference in patients with steal symptoms in the two groups
- Acute changes in vasodilating and anti-inflammatory factors after a single FIR treatment [ Time Frame: After 40 minutes of FIR treatment ]In a subgroup of patients we want to study the acute changes of the following markers during a FIR treatment (SAA, VCAM, ICAM, sE-selectin, vWF, nitrite, nitrate, ADMA, HO-1, endothelia, PGE2, ILbeta, IL6, IL8, TNF-alpha, TGF-beta, MCP-1)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011072
|Contact: Kristine Lindhard, Doctoremail@example.com|
|Contact: Ditte Hansen, Doctor||+45 firstname.lastname@example.org|
|Study Chair:||Ditte Hansen, Doctor||Herlev Hospital, Department of Nephrology|