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

NCT03989141 | Completed DMC

• 1 other identifier: Buttonhole project
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

End-stage Renal Disease (ESRD)

Keywords

Buttonhole cannulation; Cannulation technique; Dialysis access; Hemodialysis; Arterio venous fistula

Outcome Measures

Primary Outcomes (1)

• Buttonhole survival

  Cannulation with a blunt needle in the buttonhole tunnel track is possible. Technique failure and non-survival is defined as inability to insert a blunt needle into the buttonhole tunnel tracks in three consecutive dialysis or inability to cannulate the established buttonhole track for more than two weeks.

  Follow up for 1 year after completed creation of buttonhole tunnel

Secondary Outcomes (1)

• Patient perceived pain post-needling

  Measured at each cannulation until completed creation of buttonhole tunnel track (up to 24 dialyses=8 weeks)

Other Outcomes (2)

• Number of dialyses required to create a buttonhole tunnel track

  up to 24 dialyses=8 weeks

• AV fistula associated event

  Follow up for 1 year after completed creation of buttonhole tunnel

Study Arms (2)

Repeated cannulation Buttonhole

EXPERIMENTAL

The intervention group (I): repeated needling into the same site in the AVF with sharp needles (4-6 pieces) at each dialysis (1-3 dialyses) creating a buttonhole tunnel track where cannulation with a blunt needle is possible.

Procedure: Repeated cannulation Buttonhole.

Single cannulation Buttonhole

ACTIVE COMPARATOR

The control group (C): needling into the same site in the AVF with 1 sharp needle at each dialysis (6-12 dialyses) creating a buttonhole tunnel track, where cannulation with a blunt needle is possible. .

Procedure: Single cannulation Buttonhole.

Interventions

Repeated cannulation Buttonhole. PROCEDURE

The intervention group (I): repeated needling into the same site in the AVF with sharp needles (4-6 pieces) at each dialysis (1-3 dialyses) creating a buttonhole tunnel track where cannulation with a blunt needle is possible.

Also known as: Intervention method

Repeated cannulation Buttonhole

Single cannulation Buttonhole. PROCEDURE

The control group (C): needling into the same site in the AVF with 1 sharp needle at each dialysis (6-12 dialyses) creating a buttonhole tunnel track, where cannulation with a blunt needle is possible. .

Also known as: Standard method

Single cannulation Buttonhole

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• patients with an artificial heart valve
• patients in high dose immunosuppressive treatment
• patients with infections in their buttonholes
• patients who are unable to provide informed consent

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Kolding Sygehus: collaborator

Study Sites (2)

Hospital South West Jutland, Esbjerg

Esbjerg, 6700, Denmark

Location

Kolding Sygehus

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Mette KM Axelsen, RN,MHS

  Hospital SWJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nurse specialist

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 18, 2019
• Study Start: May 20, 2019
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)