NCT03989141

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

Completed NA Last updated 10 March 2025

What this trial tests

NA trial testing Repeated cannulation Buttonhole. in End-stage Renal Disease (ESRD) in 43 participants. Completed in 16 October 2024.

Timeline

20 May 2019

Primary endpoint
16 October 2024

16 October 2024

Quick facts

Lead sponsor	Esbjerg Hospital - University Hospital of Southern Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	20 May 2019
Primary completion	16 October 2024
Estimated completion	16 October 2024
Sites	2 locations across Denmark

Drugs / interventions tested

• Repeated cannulation Buttonhole.
• Single cannulation Buttonhole.

Conditions studied

• End-stage Renal Disease (ESRD) — all drugs for End-stage Renal Disease (ESRD) →

Sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Who can join

18 and older, any sex, with End-stage Renal Disease (ESRD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.