Arterio-venous FistulaNCT04011072
Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients
A study testing Far infrared radiation in people with Arterio-venous Fistula, run by Herlev and Gentofte Hospital at 9 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula
- What is being tested?
- Far infrared radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 9 sitesDenmark
- Study dates
- 3 Oct 2019to 29 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Rigshospitalet
Copenhagen
Frederiksberg Hospital
Frederiksberg
Herlev Hospital
Herlev
Hilleroed Hospital
Hillerød
Holbæk Hospital
Holbæk
Hvidovre Hospital
Hvidovre
Nykøbing Falster Hospital
Nykøbing Falster
Roskilde Hospital
Roskilde
Slagelse Hospital
Slagelse
About this study
Official title: Effect of Far Infrared Therapy on Arteriovenous Fistulas Maturation, Survival and Stenosis. A Randomized, Controlled Open-labeled Multicenter Study
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.
Read more
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.
Read the detailed description
Background:
The number of hemodialysis patients in the world are increasing. In order to receive an efficient dialysis, the patient needs a well-functioning and stable vascular access. Presently there is three options: an arteriovenous fistula (AVF), an arteriovenous graft (AVG) and a central venous catheter (CVC). CVCs are associated with an increased risk of stenosis of the central vessels, thrombosis in the AVF, infections and death. AVGs are associated with increased risk of infections, stenosis in the AVG and loss of access. This is why, the AVF is the preferred vascular access. But this vascular access does not come without risks. After the creation of an AVF there is a risk of 50 % for never maturing, which means the AVF cannot be used. Furthermore, the risk of stenosis in the AVF is also high, up to 67 % of the AVFs will have a stenosis, that needs an intervention. During this time the patient needs an alternative vascular access, such as a central venous catheter, which is related to an increased risk of infection, more hospital days and death.
The maturation of the AVF depends on several patient related, but also surgically related factors. Factors such as comorbidity, female sex, length of end stage renal disease, anatomy of the vessel, surveillance after AVF placement and the operations itself have all been shown to affect the AVF maturation. Fistula stenosis emerges from an endothelial dysfunction, inflammation and smooth muscle cell proliferation leading to intimal hyperplasia and in the end stenosis. Factors such as increased blood flow, inflammation, uremia and percutaneous transluminal angioplasty has been shown to affect the stenosis, It is not well understood, which molecular mechanism are responsible for the intimal hyperplasia.
There are few and not well established studies on how to improve the AVF survival and maturation.
Far infrared radiation (FIR) is an electromagnetic radiation (heat therapy), that is given directly on the skin above the AVF. In a few single center studies in Taiwan it has been shown to decrease the risk of stenosis and increase the fistula survival and maturation. However another study is disputing this. The mechanism behind FIR and better fistula survival is not fully understood. The infrared light is supposed to have a thermal effect, which leads to vasodilatation and a non-thermal effect, which influence the endothelial function and vasodilation and thereby it may decrease the inflammation and proliferation in the fistula, primarily through the releasing of several anti-inflammatory and vasodilating factors. This is not well documented.
Hypothesis:
Treatment with FIR for 40 minutes three times a week on the patients AVF will improve the AVF survival and maturation
Method:
This study is a randomized, controlled multicenter study on western patients
There will be 2 patient categories:
- A group (82 patients) of dialysis patients with a newly created AF
- A group (104 patients) of dialysis patients with an existing AVF
The patients will randomly be randomized 1:1 to either the treatment group or a control group. For group 2 the patients will be block randomized according to their access flow (AF) (above or below 950 ml/min). Furthermore these patients will be stratified according to interventions in there AVF (no interventions >/= 1 intervention) For the FIR treatment Ws Far Infrared Therapy Unit, model TY-102F (Medical device Class 11a CE0434) is being used. The patients will receive 40 minutes of infrared radiation on the skin of their fistula during each dialysis treatment for one year. The control group will not receive any FIR treatment, but will be followed according to the protocol and in line with the treatment group.
The patients will be followed until end of study or lost-to-follow-up (death, transplantations, change of renal replacement therapy, abandoned AVF, change of vascular access to CVC, consent withdrawal or if the patients moves away).
In order to explore the long term effects of FIR the patients will be followed for an extra 6 months according to the endpoints. In a subset of 2x20 patients of the randomized controlled trial we further wish to explore the influence of infrared therapy on endothelial function and inflammation during a FIR treatment session. Blood samples will be collected before and immediately after infrared treatment directly from the treatment site, since 2 needles are placed in the fistula during the dialysis treatment. The same samples will be collected in the control group and in the intervention group during the dialysis before the first infrared intervention in order to reduce the interindividual variation in the biomarkers.The changes in markers of endothelial dysfunction and inflammation during treatment and control dialysis session will be examined and compared.
Furthermore a blood sample from each patient will be collected at study start. The predictive value of the biomarkers of endothelial dysfunction and inflammation for the treatment response to infrared therapy and the prognosis for fistula maturation, stenosis and survival will be evaluated after the randomised controlled trial has ended.
Arterial stiffness (measured by Mobil-O-Graph) will also be evaluated as a marker for fistula survival and maturation.
A total of 186 participants will be recruited from 9 dialysis centres. If the study shows positive results, the implication of FIR in the clinic will have a huge beneficial effect for the hemodialysis patients vascular access and perhaps also patient survival. FIR is an easy treatment with a low cost-effectiveness and minimal or no side effects for the patient.
- Conditions
- Arterio-venous Fistula
- Being tested
- Far infrared radiation
- Keywords
- Hemodialysis, Infrared therapy, Stenosis, Maturation, Arteriovenous fistula survival
- Medical subject headings
- Arteriovenous Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far infrared radiationRadiation
Also called FIR
The treatment group will receive FIR for 40 minutes on the skin above the fistula during each dialysis session for one year.
| Study group | Role | What they receive |
|---|---|---|
| Infrared treatment arm | Active comparator | Far infrared radiation will be given for 40 minutes on the skin above the patients fistula in each dialysis session for one year Receives: Radiation: Far infrared radiation |
| Control arm | No intervention | The control group will not receive any intervention, but will be followed with the same data as the treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fistula maturation for the incident fistulae
Time from placement of the fistula to successful cannulation with 2 needles and successful hemodialysis treatment
Measured: After 12 months
Difference in number of fistula intervention for the prevalent fistulae
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
Measured: After 12 months
Secondary outcomes (11)
Difference in number of fistula interventions in the incident fistula group
Difference in the number of fistula intervention in the groups with a newly places fistula
Measured: After 12 months
Difference in the fistula diameter in the incident fistula group
Is there a difference in the diameter measured by ultrasound between the 2 groups with patients with a newly places fistula
Measured: After 12 months
Number of abandoned fistulae in incident and prevalent groups
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
Measured: After 12 months
The incidence of primary patency in the incident group
How many of the fistulas in the group with a new fistula needs an intervention in order to get a functioning fistula
Measured: After 12 months
Number of patients with a never functioning fistula in the incident group
How many patients in the newly places fistula group will never have a functioning fistula
Measured: After 12 months
Change in access flow in the incident and prevalent group
Does the access flow change between the control and treatment group
Measured: After 12 moths
Baseline value in serum amyloid A as a predictor for AVF survival and stenosis
Before study start the following markers will be explored : Serum Amyloid A (in Ug/ml),
Measured: After 12 months
Baseline value in adhesion molecules, heme-oxygenase and ADMA and selectin as a predictor for AVF survival stenosis
Before study start the following change in markers will be explored: vascular cell adhesion molecule (in ng/ml), intercellular adhesion molecule (in ng/ml), sE-selectin (in ng/ml), assymetric dimethylarginine (in ng/ml), heme-oxygenase-1 (in ng/ml)
Measured: After 12 months
Baseline value in von willebrand factor as a predictor for AVF survival stenosis
Before study start the following change in markers will be explored: vWF in ml-1)
Measured: After 12 months
Baseline in nitrite and nitrate as a predictor for AVF survival stenosis
Before study start the following change in markers will be explored: nitrite (in uM), nitrate (in uM)
Measured: After 12 months
Baseline in different biomarkers as a predictor for AVF survival stenosis
Before study start the following change in markers will be explored: endothelin (in pg/ml), prostaglandin E2 (in pg/ml, Interleukin-beta (pg/ml), Interleukin-6 (in pg/ml), Interleukin-8 (in pg/ml), tumor necrosis factor-alpha (in pg/ml), transformin growth factor-beta (in pg/ml) and monocyte chemoattractant protein 1 (in pg/ml).
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start3 Oct 2019
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Arterio-venous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hillerod Hospital, Denmark, Holbaek Sygehus, Zealand University Hospital
- Responsible party
- Principal investigator, Kristine Lindhard, Herlev and Gentofte Hospital
- Investigators
- Ditte Hansen, Doctor, Study chair, Herlev Hospital, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011072
- Sponsor's protocol ID
- FIR HD
- Status last verified
- Feb 2024
- First submitted
- 27 Jun 2019
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lacson E Jr, Wang W, Hakim RM, Teng M, Lazarus JM. Associates of mortality and hospitalization in hemodialysis: potentially actionable laboratory variables and vascular access. Am J Kidney Dis. 2009 Jan;53(1):79-90. doi: 10.1053/j.ajkd.2008.07.031. Epub 2008 Oct 18.
PubMed 18930570Bray BD, Boyd J, Daly C, Donaldson K, Doyle A, Fox JG, Innes A, Khan I, Peel RK, Severn A, Shilliday I, Simpson K, Stewart GA, Traynor J, Metcalfe W; Scottish Renal Registry. Vascular access type and risk of mortality in a national prospective cohort of haemodialysis patients. QJM. 2012 Nov;105(11):1097-103. doi: 10.1093/qjmed/hcs143. Epub 2012 Aug 20.
PubMed 22908320Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
PubMed 16813991Vanholder R, Canaud B, Fluck R, Jadoul M, Labriola L, Marti-Monros A, Tordoir J, Van Biesen W. Diagnosis, prevention and treatment of haemodialysis catheter-related bloodstream infections (CRBSI): a position statement of European Renal Best Practice (ERBP). NDT Plus. 2010 Jun;3(3):234-246. doi: 10.1093/ndtplus/sfq041. No abstract available.
PubMed 30792802Dhingra RK, Young EW, Hulbert-Shearon TE, Leavey SF, Port FK. Type of vascular access and mortality in U.S. hemodialysis patients. Kidney Int. 2001 Oct;60(4):1443-51. doi: 10.1046/j.1523-1755.2001.00947.x.
PubMed 11576358Rayner HC, Pisoni RL, Gillespie BW, Goodkin DA, Akiba T, Akizawa T, Saito A, Young EW, Port FK; Dialysis Outcomes and Practice Patterns Study. Creation, cannulation and survival of arteriovenous fistulae: data from the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2003 Jan;63(1):323-30. doi: 10.1046/j.1523-1755.2003.00724.x.
PubMed 12472799Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.
PubMed 24183112Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012 Mar;55(3):849-55. doi: 10.1016/j.jvs.2011.07.095. Epub 2011 Nov 8.
PubMed 22070937Bashar K, Conlon PJ, Kheirelseid EA, Aherne T, Walsh SR, Leahy A. Arteriovenous fistula in dialysis patients: Factors implicated in early and late AVF maturation failure. Surgeon. 2016 Oct;14(5):294-300. doi: 10.1016/j.surge.2016.02.001. Epub 2016 Mar 15.
PubMed 26988630Brahmbhatt A, Remuzzi A, Franzoni M, Misra S. The molecular mechanisms of hemodialysis vascular access failure. Kidney Int. 2016 Feb;89(2):303-316. doi: 10.1016/j.kint.2015.12.019.
PubMed 26806833Lin CC, Liu XM, Peyton K, Wang H, Yang WC, Lin SJ, Durante W. Far infrared therapy inhibits vascular endothelial inflammation via the induction of heme oxygenase-1. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):739-45. doi: 10.1161/ATVBAHA.107.160085. Epub 2008 Jan 17.
PubMed 18202320Shui S, Wang X, Chiang JY, Zheng L. Far-infrared therapy for cardiovascular, autoimmune, and other chronic health problems: A systematic review. Exp Biol Med (Maywood). 2015 Oct;240(10):1257-65. doi: 10.1177/1535370215573391. Epub 2015 Feb 25.
PubMed 25716016Lin CC, Yang WC, Chen MC, Liu WS, Yang CY, Lee PC. Effect of far infrared therapy on arteriovenous fistula maturation: an open-label randomized controlled trial. Am J Kidney Dis. 2013 Aug;62(2):304-11. doi: 10.1053/j.ajkd.2013.01.015. Epub 2013 Mar 6.
PubMed 23474008Lin CC, Chang CF, Lai MY, Chen TW, Lee PC, Yang WC. Far-infrared therapy: a novel treatment to improve access blood flow and unassisted patency of arteriovenous fistula in hemodialysis patients. J Am Soc Nephrol. 2007 Mar;18(3):985-92. doi: 10.1681/ASN.2006050534. Epub 2007 Jan 31.
PubMed 17267744Lai CC, Fang HC, Mar GY, Liou JC, Tseng CJ, Liu CP. Post-angioplasty far infrared radiation therapy improves 1-year angioplasty-free hemodialysis access patency of recurrent obstructive lesions. Eur J Vasc Endovasc Surg. 2013 Dec;46(6):726-32. doi: 10.1016/j.ejvs.2013.09.018. Epub 2013 Sep 25.
PubMed 24119468
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Far Infrared Therapy on Arteriovenous Fistulas Maturation, Survival and Stenosis. A Randomized, Controlled Open-labeled Multicenter Study
- ClinicalTrials.gov ID
- NCT04011072
- Acronym / sponsor ID
- FIR HD
- Conditions
- Arterio-venous Fistula
- Keywords
- Hemodialysis, Infrared therapy, Stenosis, Maturation, Arteriovenous fistula survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Hillerod Hospital, Denmark, Holbaek Sygehus, Zealand University Hospital
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
The number of hemodialysis patients in the world are increasing. In order to receive an efficient dialysis, the patient needs a well-functioning and stable vascular access. Presently there is three options: an arteriovenous fistula (AVF), an arteriovenous graft (AVG) and a central venous catheter (CVC). CVCs are associated with an increased risk of stenosis of the central vessels, thrombosis in the AVF, infections and death. AVGs are associated with increased risk of infections, stenosis in the AVG and loss of access. This is why, the AVF is the preferred vascular access. But this vascular access does not come without risks. After the creation of an AVF there is a risk of 50 % for never maturing, which means the AVF cannot be used. Furthermore, the risk of stenosis in the AVF is also high, up to 67 % of the AVFs will have a stenosis, that needs an intervention. During this time the patient needs an alternative vascular access, such as a central venous catheter, which is related to an increased risk of infection, more hospital days and death.
The maturation of the AVF depends on several patient related, but also surgically related factors. Factors such as comorbidity, female sex, length of end stage renal disease, anatomy of the vessel, surveillance after AVF placement and the operations itself have all been shown to affect the AVF maturation. Fistula stenosis emerges from an endothelial dysfunction, inflammation and smooth muscle cell proliferation leading to intimal hyperplasia and in the end stenosis. Factors such as increased blood flow, inflammation, uremia and percutaneous transluminal angioplasty has been shown to affect the stenosis, It is not well understood, which molecular mechanism are responsible for the intimal hyperplasia.
There are few and not well established studies on how to improve the AVF survival and maturation.
Far infrared radiation (FIR) is an electromagnetic radiation (heat therapy), that is given directly on the skin above the AVF. In a few single center studies in Taiwan it has been shown to decrease the risk of stenosis and increase the fistula survival and maturation. However another study is disputing this. The mechanism behind FIR and better fistula survival is not fully understood. The infrared light is supposed to have a thermal effect, which leads to vasodilatation and a non-thermal effect, which influence the endothelial function and vasodilation and thereby it may decrease the inflammation and proliferation in the fistula, primarily through the releasing of several anti-inflammatory and vasodilating factors. This is not well documented.
Hypothesis:
Treatment with FIR for 40 minutes three times a week on the patients AVF will improve the AVF survival and maturation
Method:
This study is a randomized, controlled multicenter study on western patients
There will be 2 patient categories:
- A group (82 patients) of dialysis patients with a newly created AF
- A group (104 patients) of dialysis patients with an existing AVF
The patients will randomly be randomized 1:1 to either the treatment group or a control group. For group 2 the patients will be block randomized according to their access flow (AF) (above or below 950 ml/min). Furthermore these patients will be stratified according to interventions in there AVF (no interventions >/= 1 intervention) For the FIR treatment Ws Far Infrared Therapy Unit, model TY-102F (Medical device Class 11a CE0434) is being used. The patients will receive 40 minutes of infrared radiation on the skin of their fistula during each dialysis treatment for one year. The control group will not receive any FIR treatment, but will be followed according to the protocol and in line with the treatment group.
The patients will be followed until end of study or lost-to-follow-up (death, transplantations, change of renal replacement therapy, abandoned AVF, change of vascular access to CVC, consent withdrawal or if the patients moves away).
In order to explore the long term effects of FIR the patients will be followed for an extra 6 months according to the endpoints. In a subset of 2x20 patients of the randomized controlled trial we further wish to explore the influence of infrared therapy on endothelial function and inflammation during a FIR treatment session. Blood samples will be collected before and immediately after infrared treatment directly from the treatment site, since 2 needles are placed in the fistula during the dialysis treatment. The same samples will be collected in the control group and in the intervention group during the dialysis before the first infrared intervention in order to reduce the interindividual variation in the biomarkers.The changes in markers of endothelial dysfunction and inflammation during treatment and control dialysis session will be examined and compared.
Furthermore a blood sample from each patient will be collected at study start. The predictive value of the biomarkers of endothelial dysfunction and inflammation for the treatment response to infrared therapy and the prognosis for fistula maturation, stenosis and survival will be evaluated after the randomised controlled trial has ended.
Arterial stiffness (measured by Mobil-O-Graph) will also be evaluated as a marker for fistula survival and maturation.
A total of 186 participants will be recruited from 9 dialysis centres. If the study shows positive results, the implication of FIR in the clinic will have a huge beneficial effect for the hemodialysis patients vascular access and perhaps also patient survival. FIR is an easy treatment with a low cost-effectiveness and minimal or no side effects for the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrared treatment arm | Active comparator | Radiation: Far infrared radiationFar infrared radiation will be given for 40 minutes on the skin above the patients fistula in each dialysis session for one year |
| Control arm | No intervention | –The control group will not receive any intervention, but will be followed with the same data as the treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Patients in chronic hemodialysis with a functioning AVF
- Patients of 18 yeas of age or above
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far infrared radiationAlso: FIRThe treatment group will receive FIR for 40 minutes on the skin above the fistula during each dialysis session for one year. | Radiation | Infrared treatment arm |
Primary outcome
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
11 secondary outcomes
Difference in number of fistula interventions in the incident fistula group
Time frame: After 12 months
Difference in the fistula diameter in the incident fistula group
Time frame: After 12 months
Number of abandoned fistulae in incident and prevalent groups
Time frame: After 12 months
The incidence of primary patency in the incident group
Time frame: After 12 months
Number of patients with a never functioning fistula in the incident group
Time frame: After 12 months
Change in access flow in the incident and prevalent group
Time frame: After 12 moths
Baseline value in serum amyloid A as a predictor for AVF survival and stenosis
Time frame: After 12 months
Baseline value in adhesion molecules, heme-oxygenase and ADMA and selectin as a predictor for AVF survival stenosis
Time frame: After 12 months
Baseline value in von willebrand factor as a predictor for AVF survival stenosis
Time frame: After 12 months
Baseline in nitrite and nitrate as a predictor for AVF survival stenosis
Time frame: After 12 months
Baseline in different biomarkers as a predictor for AVF survival stenosis
Time frame: After 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 18930570Lacson E Jr, Wang W, Hakim RM, Teng M, Lazarus JM. Associates of mortality and hospitalization in hemodialysis: potentially actionable laboratory variables and vascular access. Am J Kidney Dis. 2009 Jan;53(1):79-90. doi: 10.1053/j.ajkd.2008.07.031. Epub 2008 Oct 18.
- Background: PubMed 22908320Bray BD, Boyd J, Daly C, Donaldson K, Doyle A, Fox JG, Innes A, Khan I, Peel RK, Severn A, Shilliday I, Simpson K, Stewart GA, Traynor J, Metcalfe W; Scottish Renal Registry. Vascular access type and risk of mortality in a national prospective cohort of haemodialysis patients. QJM. 2012 Nov;105(11):1097-103. doi: 10.1093/qjmed/hcs143. Epub 2012 Aug 20.
- Background: PubMed 16813991Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
- Background: PubMed 30792802Vanholder R, Canaud B, Fluck R, Jadoul M, Labriola L, Marti-Monros A, Tordoir J, Van Biesen W. Diagnosis, prevention and treatment of haemodialysis catheter-related bloodstream infections (CRBSI): a position statement of European Renal Best Practice (ERBP). NDT Plus. 2010 Jun;3(3):234-246. doi: 10.1093/ndtplus/sfq041. No abstract available.
- Background: PubMed 11576358Dhingra RK, Young EW, Hulbert-Shearon TE, Leavey SF, Port FK. Type of vascular access and mortality in U.S. hemodialysis patients. Kidney Int. 2001 Oct;60(4):1443-51. doi: 10.1046/j.1523-1755.2001.00947.x.
- Background: PubMed 12472799Rayner HC, Pisoni RL, Gillespie BW, Goodkin DA, Akiba T, Akizawa T, Saito A, Young EW, Port FK; Dialysis Outcomes and Practice Patterns Study. Creation, cannulation and survival of arteriovenous fistulae: data from the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2003 Jan;63(1):323-30. doi: 10.1046/j.1523-1755.2003.00724.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ditte Hansen, Doctor study chair
Herlev Hospital, Department of Nephrology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Far infrared radiation in people with Arterio-venous Fistula, run by Herlev and Gentofte Hospital at 9 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to fistula maturation for the incident fistulae (time frame: After 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011072, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.