Abstract
BackgroundAn arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis treatment. After creation many of the AVFs will never mature or if functioning will need an intervention within 1 year due to an AVF stenosis. Studies investigating possible therapies that improves the AVF maturation and survival are scarce. Far infrared therapy (FIR) has shown promising results. In minor single centre and industry supported trials FIR has shown improved AVF maturation and survival. There is a need of a randomized multicentre controlled trial to examine the effect of FIR on the AVF maturation and survival and to explore the possible AVF protective mechanism induced by the FIR treatment.MethodsThis investigator initiated, randomized, controlled, open-labeled, multicenter clinical trial will examine the effect of FIR on AVF maturation in patients with a newly created AVF (incident) and AVF patency rate after 1 year of treatment in patients with an existing AVF (prevalent) compared to a control group. The intervention group will receive FIR to the skin above their AVF three times a week for 1 year. The control group will be observed without any treatment. The primary outcome for incident AVFs is the time from surgically creation of the AVF to successful cannulation. The primary outcome for the prevalent AVFs is the difference in number of AVFs without intervention and still functioning in the treatment and control group after 12 months. Furthermore, the acute changes in inflammatory and vasodilating factors during FIR will be explored. Arterial stiffness as a marker of long term AVF patency will also be examined.DiscussionFIR is a promising new treatment modality that may potentially lead to improved AVF maturation and survival. This randomized controlled open-labelled trial will investigate the effect of FIR and its possible mechanisms.Trial registrationClinicaltrialsgov NCT04011072 (7th of July 2019).
Highlights
An arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis treatment
The present paper describes the design and rationale of a randomized, controlled, open-labeled multicenter trial of the effect of Far infrared therapy (FIR) on AVF maturation and on number of AVFs without intervention still functioning after 1 year
The present study will examine the effect of FIR treatment on AVF maturation and overall patency rate through a randomized, multicenter, open-labelled trial
Summary
An arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis treatment. After creation many of the AVFs will never mature or if functioning will need an intervention within 1 year due to an AVF stenosis. Studies investigating possible therapies that improves the AVF maturation and survival are scarce. In minor single centre and industry supported trials FIR has shown improved AVF maturation and survival. CVCs are associated with an increased risk of stenosis of the central thoracic vessels, thrombosis in a present AVF, local and systemic infections and death [4,5,6,7]. During the period with a malfunctioning AVF, the patient may need a CVC as an alternative vascular access which leads to an increased risk of infection, more hospital days and death [6]. Female sex, anatomic location of the AVF (primarily radio-cephalic), small vein diameter, comorbidity, surgeon experience and perhaps arterial stiffness, are all risk factors that influence the AVF survival [10, 12,13,14,15]
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