End-stage Renal Disease (ESRD)NCT03989141
Creating a Buttonhole Tunnel Track by Repeated Needling of the AV Fistula on the Same Day in Patients on Hemodialysis.
A study testing Repeated cannulation Buttonhole. and Single cannulation Buttonhole. in people with End-stage Renal Disease (ESRD), run by Esbjerg Hospital - University Hospital of Southern Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD)
- What is being tested?
- Repeated cannulation Buttonhole. and Single cannulation Buttonhole.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 May 2019to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hospital South West Jutland, Esbjerg
Esbjerg, 6700
Kolding Sygehus
Kolding, 6000
About this study
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.
Read the detailed description
Background: See above. Aims:To study whether a new method of creating a buttonhole tunnel tracks can reduce the incidence of buttonhole technique failure and the patients pain with needling.
Patients and Methods: A randomized, multi-center study enrolling 42 patients in hemodialysis from two HD units in Denmark. The study will begin end of May 2019.
Participants are randomized into 2 groups where cannulation will be carried out by a small group of dialysis nurses with experience and skills in buttonhole cannulation. In both groups the same nurse will carry out the cannulation the first four dialysis sessions. At the following sessions the cannulation will be carried out by the nurse/nurses responsible for the patient. The procedures throughout the study will be the same in both participating centers.
The control group (K): creating buttonhole tunnels according to the standard method, ie. cannulation with a single sharp cannula in the AVF at each dialysis for 6-12 dialyses until a blunt needle can be inserted.
The intervention group (I): creating buttonhole tunnels according to the new method, ie. repeated cannulation with several sharp needles (4-6 pieces) at each dialysis for 1-3 dialyses until a blunt cannula can be inserted.
The creation of a buttonhole tunnel track is defined as completed when two consecutive dialyses have been carried out with no use of sharp needles, however no longer than 24 dialysis sessions.Thus, the period of time will be of different length for each participant. In the period until the tunnel is created, data will be collected at each dialyses regarding number of cannulations, type of needle (sharp or blunt), cannulator and patient-experienced pain with needling.
The primary outcome is buttonhole technique failure defined as the need for cannulations carried out using sharp needles in the buttonhole for three consecutive dialyses or in case lack of ability to insert blunt needles in the buttonhole for 2 weeks.
Follow-up from the date of the completed creation of the buttonhole tunnel track in both groups:
12 month ongoing follow-up of the primary outcome buttonhole survival and the secondary outcomes AVF associated infections, complications and AVF survival.
Sample size:The power calculation is based on the expected incidence of the primary outcome measure: buttonhole technique failure. Based on calculations in the two dialysis centers from randomly selected patients with buttonhole tunnels made using the intervention and the control method, it appears that the estimated buttonhole technique failure is 10 % and 30 %, respectively.
Drop-off rate is estimated to 30%. The number of participants for the study is calculated at 21 subjects in each group to achieve a power of 0.8 with a type error rate of 0.5.
Intention-to-treat analysis will be carried out. Censoring in case of death, if the person wants to withdraw from the study or moves, AV fistula failure for non-buttonhole associated causes and kidney transplant.
Statistical analysis:The baseline characteristics of the study population will be presented as counts and proportions and compared between randomization groups with chi-square test / Fisher's exact test (depending on number of observations) for categorical variables. Continous variables will be presented as mean (SD), respectively, median (IQR) depending on normality of data and compared between groups by t-test, respectively, Wilcoxon rank-sum test. Normality will be evaluated by quantile plots and Shapiro-Wilks test. Moreover, repeated measurements will be compared by mixed effects models. Time to event outcomes will be compared by the Kaplan-Meier method and tested by log-rank test, furthermore discrete time survival methods will be applied as a sensitivity analysis. P-values <0.05 are regarded as statistically significant. Follow-up will be censored at 1 year. Statistical analysis will be performed using Stata, version 11.0 (StataCorp, College Station, Tex., USA).
- Conditions
- End-stage Renal Disease (ESRD)
- Being tested
- Repeated cannulation Buttonhole., Single cannulation Buttonhole.
- Keywords
- Buttonhole cannulation, Cannulation technique, Dialysis access, Hemodialysis, Arterio venous fistula
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated cannulation Buttonhole.Procedure or surgery
Also called Intervention method
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.
Single cannulation Buttonhole.Procedure or surgery
Also called Standard method
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. .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. . Receives: Procedure: Single cannulation Buttonhole. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow up for 1 year after completed creation of buttonhole tunnel
Secondary outcomes (1)
Patient perceived pain post-needling
Measuring the patients pain at buttonhole needling using a validated numeric rating scale (NRS) for pain with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable"
Measured: Measured at each cannulation until completed creation of buttonhole tunnel track (up to 24 dialyses=8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start20 May 2019
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus
- Responsible party
- Principal investigator, Mette Axelsen, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Mette KM Axelsen, RN,MHS, Principal investigator, Hospital SWJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989141
- Sponsor's protocol ID
- Buttonhole project
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2019
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Axelsen M, Lagoni N, Vandborg S, Hansen H, Gram B. Same-day multiple-cannulation: A promising alternative method for establishing buttonhole tracks in hemodialysis patients-A multicenter randomized controlled trial. J Vasc Access. 2026 Nov 2:11297298261494052. doi: 10.1177/11297298261494052. Online ahead of print.
PubMed 42972846
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Buttonhole Tunnel Track by Repeated Needling of the AV Fistula on the Same Day in Patients on Hemodialysis.
- ClinicalTrials.gov ID
- NCT03989141
- Acronym / sponsor ID
- Buttonhole project
- Conditions
- End-stage Renal Disease (ESRD)
- Keywords
- Buttonhole cannulation, Cannulation technique, Dialysis access, Hemodialysis, Arterio venous fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Kolding Sygehus
- Study start
- 20 May 2019 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: See above. Aims:To study whether a new method of creating a buttonhole tunnel tracks can reduce the incidence of buttonhole technique failure and the patients pain with needling.
Patients and Methods: A randomized, multi-center study enrolling 42 patients in hemodialysis from two HD units in Denmark. The study will begin end of May 2019.
Participants are randomized into 2 groups where cannulation will be carried out by a small group of dialysis nurses with experience and skills in buttonhole cannulation. In both groups the same nurse will carry out the cannulation the first four dialysis sessions. At the following sessions the cannulation will be carried out by the nurse/nurses responsible for the patient. The procedures throughout the study will be the same in both participating centers.
The control group (K): creating buttonhole tunnels according to the standard method, ie. cannulation with a single sharp cannula in the AVF at each dialysis for 6-12 dialyses until a blunt needle can be inserted.
The intervention group (I): creating buttonhole tunnels according to the new method, ie. repeated cannulation with several sharp needles (4-6 pieces) at each dialysis for 1-3 dialyses until a blunt cannula can be inserted.
The creation of a buttonhole tunnel track is defined as completed when two consecutive dialyses have been carried out with no use of sharp needles, however no longer than 24 dialysis sessions.Thus, the period of time will be of different length for each participant. In the period until the tunnel is created, data will be collected at each dialyses regarding number of cannulations, type of needle (sharp or blunt), cannulator and patient-experienced pain with needling.
The primary outcome is buttonhole technique failure defined as the need for cannulations carried out using sharp needles in the buttonhole for three consecutive dialyses or in case lack of ability to insert blunt needles in the buttonhole for 2 weeks.
Follow-up from the date of the completed creation of the buttonhole tunnel track in both groups:
12 month ongoing follow-up of the primary outcome buttonhole survival and the secondary outcomes AVF associated infections, complications and AVF survival.
Sample size:The power calculation is based on the expected incidence of the primary outcome measure: buttonhole technique failure. Based on calculations in the two dialysis centers from randomly selected patients with buttonhole tunnels made using the intervention and the control method, it appears that the estimated buttonhole technique failure is 10 % and 30 %, respectively.
Drop-off rate is estimated to 30%. The number of participants for the study is calculated at 21 subjects in each group to achieve a power of 0.8 with a type error rate of 0.5.
Intention-to-treat analysis will be carried out. Censoring in case of death, if the person wants to withdraw from the study or moves, AV fistula failure for non-buttonhole associated causes and kidney transplant.
Statistical analysis:The baseline characteristics of the study population will be presented as counts and proportions and compared between randomization groups with chi-square test / Fisher's exact test (depending on number of observations) for categorical variables. Continous variables will be presented as mean (SD), respectively, median (IQR) depending on normality of data and compared between groups by t-test, respectively, Wilcoxon rank-sum test. Normality will be evaluated by quantile plots and Shapiro-Wilks test. Moreover, repeated measurements will be compared by mixed effects models. Time to event outcomes will be compared by the Kaplan-Meier method and tested by log-rank test, furthermore discrete time survival methods will be applied as a sensitivity analysis. P-values <0.05 are regarded as statistically significant. Follow-up will be censored at 1 year. Statistical analysis will be performed using Stata, version 11.0 (StataCorp, College Station, Tex., USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated cannulation Buttonhole | Experimental | Procedure: Repeated cannulation Buttonhole.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. |
| Single cannulation Buttonhole | Active comparator | Procedure: Single cannulation Buttonhole.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. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated cannulation Buttonhole.Also: Intervention methodThe 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 or surgery | Repeated cannulation Buttonhole |
| Single cannulation Buttonhole.Also: Standard methodThe 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 or surgery | Single cannulation Buttonhole |
Primary outcome
Buttonhole survival
Time frame: Follow up for 1 year after completed creation of buttonhole tunnel
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.
1 secondary outcome
Patient perceived pain post-needling
Time frame: Measured at each cannulation until completed creation of buttonhole tunnel track (up to 24 dialyses=8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 42972846Axelsen M, Lagoni N, Vandborg S, Hansen H, Gram B. Same-day multiple-cannulation: A promising alternative method for establishing buttonhole tracks in hemodialysis patients-A multicenter randomized controlled trial. J Vasc Access. 2026 Nov 2:11297298261494052. doi: 10.1177/11297298261494052. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette KM Axelsen, RN,MHS principal investigator
Hospital SWJ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated cannulation Buttonhole. and Single cannulation Buttonhole. in people with End-stage Renal Disease (ESRD), run by Esbjerg Hospital - University Hospital of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buttonhole survival (time frame: Follow up for 1 year after completed creation of buttonhole tunnel). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.