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Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011072
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : August 17, 2020
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Hillerod Hospital, Denmark
Holbaek Sygehus
Zealand University Hospital
Information provided by (Responsible Party):
Kristine Lindhard, Herlev and Gentofte Hospital

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.


Condition or disease Intervention/treatment Phase
Arterio-venous Fistula Radiation: Far infrared radiation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Far Infrared Therapy on Arteriovenous Fistulas Maturation, Survival and Stenosis. A Randomized, Controlled Open-labeled Multicenter Study
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Baseline value in serum amyloid A as a predictor for AVF survival and stenosis [ Time Frame: After 12 months ]
    Before study start the following markers will be explored : Serum Amyloid A (in Ug/ml),

  8. Baseline value in adhesion molecules, heme-oxygenase and ADMA and selectin as a predictor for AVF survival stenosis [ Time Frame: After 12 months ]
    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)

  9. Baseline value in von willebrand factor as a predictor for AVF survival stenosis [ Time Frame: After 12 months ]
    Before study start the following change in markers will be explored: vWF in ml-1)

  10. Baseline in nitrite and nitrate as a predictor for AVF survival stenosis [ Time Frame: After 12 months ]
    Before study start the following change in markers will be explored: nitrite (in uM), nitrate (in uM)

  11. Baseline in different biomarkers as a predictor for AVF survival stenosis [ Time Frame: After 12 months ]
    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).


Other Outcome Measures:
  1. Difference in cannulation pain in the incident and prevalent group compared with visual analogue scale [ Time Frame: After 12 months ]
    Do the patients receiving FIR treatment experience less pain during cannulation compared to the control group evaluated by the VAS (visual analogue scale) score

  2. 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

  3. Acute changes in serum amyloid A 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 Analysing Serum Amyloid A (in Ug/ml)

  4. Acute changes in adhesion molecules, heme-oxygenase and ADMA and selectin as a predictor for AVF survival stenosis 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, analysing: 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)

  5. Acute changes in von willebrand factor 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 Analysing: von WillebrandFactor (in ml-1)

  6. Acute changes in nitrite and nitrate 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 Analysing: nitrite (in uM), nitrate (in uM)

  7. Acute changes in different biomarkers 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 Analysing: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011072


Contacts
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Contact: Kristine Lindhard, Doctor +4538681977 kristine.lindhard.rasmussen@regionh.dk
Contact: Ditte Hansen, Doctor +45 3868 ditte.hansen.04@regionh.dk

Locations
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Denmark
Frederiksberg Hospital Recruiting
Frederiksberg, Denmark
Contact: Ylian Liam, Dr         
Herlev Hospital Recruiting
Herlev, Denmark
Contact: Kristine Lindhard, Dr         
Hilleroed Hospital Recruiting
Hillerød, Denmark
Contact: Marianne Berthelsen, Dr         
Holbæk Hospital Not yet recruiting
Holbæk, Denmark
Contact: Kristine Hommel, Dr         
Hvidovre Hospital Recruiting
Hvidovre, Denmark
Contact: Kristine Lindhard, Dr         
Rigshospitalet Not yet recruiting
København, Denmark
Contact: Marianne Rix, Dr         
Nykøbing Falster Hospital Recruiting
Nykøbing Falster, Denmark
Contact: Kirstine Gliese, Dr         
Roskilde Hospital Not yet recruiting
Roskilde, Denmark
Contact: Kirstine Gliese, Dr         
Slagelse Hospital Not yet recruiting
Slagelse, Denmark
Contact: Kristine Hommel, Dr         
Sponsors and Collaborators
Herlev and Gentofte Hospital
Rigshospitalet, Denmark
Hillerod Hospital, Denmark
Holbaek Sygehus
Zealand University Hospital
Investigators
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Study Chair: Ditte Hansen, Doctor Herlev Hospital, Department of Nephrology
Publications:
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.Yo ungC.TaylorM.WoodardL.MangadiK.MundaR.LeeT.AllowayR.El-KhatibM.CanaanT.PflumA.Thi ekenL.Campos-NaciffB.HuberT.BerceliS.JansenM.McCaslinG.TrahanY.DavidsonI.HwangC.L ightfootT.LivingstonC.ValenciaA.DolmatchB.FenvesA.HawkinsN.CheungA.KinikiniD.Trei manG.IhnatD.SarfatiM.LavasaniI.MaloneyM.SchlotfeldtL.BuchananC.ClarkC.CrawfordC.H amlettJ.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). pii: e003227. doi: 10.1161/JAHA.116.003227.

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Responsible Party: Kristine Lindhard, Principal Investigator, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT04011072    
Other Study ID Numbers: FIR HD
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristine Lindhard, Herlev and Gentofte Hospital:
Hemodialysis
Infrared therapy
Stenosis
Maturation
Arteriovenous fistula survival
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities