Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients

NCT04011072 | Completed

• 1 other identifier: FIR HD
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Arterio-venous Fistula

Keywords

Hemodialysis; Infrared therapy; Stenosis; Maturation; Arteriovenous fistula survival

Outcome Measures

Primary Outcomes (2)

• Time to fistula maturation for the incident fistulae

  Time from placement of the fistula to successful cannulation with 2 needles and successful hemodialysis treatment

  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

  After 12 months

Secondary Outcomes (11)

• Difference in number of fistula interventions in the incident fistula group

  After 12 months

• Difference in the fistula diameter in the incident fistula group

  After 12 months

• Number of abandoned fistulae in incident and prevalent groups

  After 12 months

• The incidence of primary patency in the incident group

  After 12 months

• Number of patients with a never functioning fistula in the incident group

  After 12 months

Other Outcomes (7)

• Difference in cannulation pain in the incident and prevalent group compared with visual analogue scale

  After 12 months

• Difference in number with steal symptoms in the incident and prevalent group

  After 12 months

• Acute changes in serum amyloid A after a single FIR treatment

  After 40 minutes of FIR treatment

Study Arms (2)

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

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

Interventions

Far infrared radiation RADIATION

The treatment group will receive FIR for 40 minutes on the skin above the fistula during each dialysis session for one year.

Also known as: FIR

Infrared treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Hillerod Hospital, Denmark: collaborator
• Holbaek Sygehus: collaborator
• Zealand University Hospital: collaborator

Study Sites (9)

Rigshospitalet

Copenhagen, Denmark

Location

Frederiksberg Hospital

Frederiksberg, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Hilleroed Hospital

Hillerød, Denmark

Location

Holbæk Hospital

Holbæk, Denmark

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

Nykøbing Falster Hospital

Nykøbing Falster, Denmark

Location

Roskilde Hospital

Roskilde, Denmark

Location

Slagelse Hospital

Slagelse, Denmark

Location

Related Publications (21)

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  PMID: 18930570 BACKGROUND

• Bray 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.

  PMID: 22908320 BACKGROUND

• Vascular 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.

  PMID: 16813991 BACKGROUND

• Vanholder 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.

  PMID: 30792802 BACKGROUND

• Dhingra 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.

  PMID: 11576358 BACKGROUND

• Rayner 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.

  PMID: 12472799 BACKGROUND

• Al-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.

  PMID: 24183112 BACKGROUND

• Smith 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.

  PMID: 22070937 BACKGROUND

• Bashar 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.

  PMID: 26988630 BACKGROUND

• Brahmbhatt 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.

  PMID: 26806833 BACKGROUND

• Lin 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.

  PMID: 18202320 BACKGROUND

• Shui 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.

  PMID: 25716016 BACKGROUND

• Lin 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.

  PMID: 23474008 BACKGROUND

• Lin 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.

  PMID: 17267744 BACKGROUND

• Lai 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.

  PMID: 24119468 BACKGROUND

• McGrogan DG, Stringer S, Cockwell P, Jesky M, Ferro C, Maxwell AP, Inston NG. Arterial stiffness alone does not explain arteriovenous fistula outcomes. J Vasc Access. 2018 Jan;19(1):63-68. doi: 10.5301/jva.5000791.

  PMID: 29076519 BACKGROUND

• Dember LM, Imrey PB, Duess MA, Hamburg NM, Larive B, Radeva M, Himmelfarb J, Kraiss LW, Kusek JW, Roy-Chaudhury P, Terry CM, Vazquez MA, Vongpatanasin W, Beck GJ, Vita JA; Hemodialysis Fistula Maturation Study GroupFeldmanH.FarberA.KaufmanJ.SternL.LeSageP.KivorkC.SoaresD.MalikovaM.AllonM.YoungC.TaylorM.WoodardL.MangadiK.MundaR.LeeT.AllowayR.El-KhatibM.CanaanT.PflumA.ThiekenL.Campos-NaciffB.HuberT.BerceliS.JansenM.McCaslinG.TrahanY.DavidsonI.HwangC.LightfootT.LivingstonC.ValenciaA.DolmatchB.FenvesA.HawkinsN.CheungA.KinikiniD.TreimanG.IhnatD.SarfatiM.LavasaniI.MaloneyM.SchlotfeldtL.BuchananC.ClarkC.CrawfordC.HamlettJ.KundzinsJ.ManahanL.WiseJ.GassmanJ.GreeneT.LiL. Vascular Function at Baseline in the Hemodialysis Fistula Maturation Study. J Am Heart Assoc. 2016 Jul 22;5(7):e003227. doi: 10.1161/JAHA.116.003227.

  PMID: 27451463 BACKGROUND

• Roy-Chaudhury P, Sukhatme VP, Cheung AK. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am Soc Nephrol. 2006 Apr;17(4):1112-27. doi: 10.1681/ASN.2005050615.

  PMID: 16565259 BACKGROUND

• Lee T, Misra S. New Insights into Dialysis Vascular Access: Molecular Targets in Arteriovenous Fistula and Arteriovenous Graft Failure and Their Potential to Improve Vascular Access Outcomes. Clin J Am Soc Nephrol. 2016 Aug 8;11(8):1504-1512. doi: 10.2215/CJN.02030216. Epub 2016 Jul 11.

  PMID: 27401527 BACKGROUND

• Lindhard K, Hansen HP, Gliese K, Hansen E, Hommel K, Jensen B, Liem Y, Lindegaard-Pedersen B, Pourarsalan M, Rix M, Heaf J, Hansen D. The effect of far infrared radiation on maturation in arteriovenous fistulas in patients on hemodialysis: A randomized controlled, multicenter trial. J Vasc Access. 2025 Nov 3:11297298251385043. doi: 10.1177/11297298251385043. Online ahead of print.

  PMID: 41178583 DERIVED

• Lindhard K, Rix M, Heaf JG, Hansen HP, Pedersen BL, Jensen BL, Hansen D. Effect of far infrared therapy on arteriovenous fistula maturation, survival and stenosis in hemodialysis patients, a randomized, controlled clinical trial: the FAITH on fistula trial. BMC Nephrol. 2021 Aug 21;22(1):283. doi: 10.1186/s12882-021-02476-x.

  PMID: 34419006 DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ditte Hansen, Doctor

  Herlev Hospital, Department of Nephrology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 8, 2019
• Study Start: October 3, 2019
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

DK (9)