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NCT03989141Completed

Creating a Buttonhole Tunnel Track by Repeated Needling of the AV Fistula on the Same Day in Patients on Hemodialysis.

Source: ClinicalTrials.gov · Last updated 10 Mar 2025

Brief summary (registry, in English)

BACKGROUND: The patients diagnosed with end stage renal disease require dialysis and for that they need to have a vascular access for hemodialysis (HD) placed. Vascular access complications are the most common cause of hospitalization among patients in HD. An AV fistula (AVF) is a surgical connection made between an artery and a vein, created by a vascular specialist, typically placed in an arm. AV fistulas are the preferred vascular access for long-term dialysis. In order to be able to carry out an adequate and uncomplicated dialysis treatment, two needles have to be placed in the fistula. It requires specialized technical ability to install well-functioning needles in the vessels of an AVF. The buttonhole technique is one of the two recommended techniques. For the buttonhole technique, two puncture sites are selected in the fistula. Here, exactly in the same spot a needle is inserted with the same angle and direction until a fibrous tunnel is formed, like a hole for an ear ring. Cannulation is now possible with blunt needles which are gentler and reduce complications. The time required to create a buttonhole tunnel is 6-12 cannulations, ie 6-12 dialyses. It is crucial for the future survival of the tunnel tracks, that a maximum of one to two persons cannulates until the track is created. This is a logistic challenge in a busy dialysis unit and may result in using a cannulation technique that is not recommended. A less time consuming method to create the buttonhole tunnel track may increase the use of the technique. A new method has been used in several dialysis units in Denmark. Using this method the tunnel tracks are created in 1-3 dialyses by repeated cannulations (4-6 needles one at a time) in the same two puncture sites in the fistula. The experiences so far indicates that this method reduces the dialysis sessions needed to create the tunnel tracks with 4-10 sessions. Thus, the logistic challenges of ensuring continuity in persons creating the tunnel track will be reduced. The purpose of the research project is to investigate whether a new method for creating buttonhole tunnels will: * Increase the number of well-functioning buttonholes. * Be less painful for the patient. * Reduce the number of dialysis needed to create the buttonhole tunnel track. * Cause unchanged or fewer fistula associated complications and infections.

Status (registry)
Completed
Study type
Interventional
Enrollment
43 (actual)
First submitted
6 Jun 2019
Start date
20 May 2019
Primary completion date
16 Oct 2024
Lead sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
NCT number
NCT03989141

What you commit to

  • Study type: Interventional
  • Participants enrolled: 43
  • From 20 May 2019 to the primary completion date, 16 Oct 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • patients with an artificial heart valve
  • patients with infections in their buttonholes

Other

  • patients in high dose immunosuppressive treatment
  • patients who are unable to provide informed consent

Who the study is looking for

  • chronic hemodialysis patients
  • at least 5 hemodialysis treatments with a blood flow ≥ 250 ml/min have been carried out
  • ability to speak and understand danish

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital South West Jutland, Esbjerg
Coordinator of this site? Confirm its status
EsbjergDenmarkUnknown status
Kolding Sygehus
Coordinator of this site? Confirm its status
KoldingDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.