Chronic Kidney DiseaseNCT01536548
Indicating Direction and Angle for Cannulating of AV-fistula in Hemodialysis Patients
A study testing Skin drawing and No skin drawing in people with Chronic Kidney Disease and Kidney Failure, run by Norwegian University of Science and Technology at 8 sites in Norway.
Trial summary
Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a "button-hole" technique is increasingly recommended. By using the same two sites for cannulation there are reports of less risk of complications and less pain for the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Kidney Failure
- What is being tested?
- Skin drawing and No skin drawing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 8 sitesNorway
- Study dates
- Mar 2012to Jul 2012
- 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 kidney disease
- hemodialysis
- arteriovenous fistula
- established buttonhole technique
- informed consent signed
Who cannot join
- child
- minor
- not speaking Norwegian
- not willing to sign informed consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Haukeland Universitetssykehus
Bergen
Bodø Sykehus
Bodø
Vestre Viken Sykehus
Drammen
Kristiansund Sykehus
Kristiansund
Sykehuset Innlandet
Lillehammer
St Olavs Hospital
Orkanger
Akershus Universitetssykehus
Oslo
St Olavs Hospital
Trondheim
About this study
Official title: Indicating Direction and Angle for Button-hole Cannulating of AV-fistula in Hemodialysis Patients - a Randomized Controlled Study
Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a "button-hole" technique is increasingly recommended. By using the same two sites for cannulation there are reports of less risk of complications and less pain for the patient. However, button-hole cannulation can be difficult for the dialysis nurse, and failing cannulations can damage the AV fistula and increase patient discomfort. The investigators therefore will test whether a simple marking on the skin of the direction and angle of cannulation used in each specific patient could improve the probability of a successful and painfree cannulation.
- Conditions
- Chronic Kidney Disease, Kidney Failure
- Being tested
- Skin drawing, No skin drawing
- Keywords
- hemodialysis, cannulation, AV-fistula, buttonhole technique
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin drawingProcedure or surgery
Mark direction and angle for cannulation with a pencil on the skin
No skin drawingProcedure or surgery
Standard practice; i.e. no marks on skin to help find correct direction and angle for introducing needles
| Study group | Role | What they receive |
|---|---|---|
| Skin drawing | Experimental | Not described Receives: Procedure: Skin drawing |
| No skin drawing | Active comparator | Not described Receives: Procedure: No skin drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful cannulations
A successful cannulation is defined as being able to insert a blunt needle in both canals at the first attempt.
Measured: 8 weeks
Secondary outcomes (3)
Difficulty of cannulation
Nurse and patients describe on a Verbal Rating Scale (1-6) how difficult the cannulation was experienced. All dialysis sessions are scored.
Measured: 8 weeks
Fear of cannulation
Patients describe on a Verbal Rating Scale (0-10) how strongly they fear the cannulation. Assessed once a week.
Measured: 8 weeks
Pain at cannulation
Patients describe on a VAS scale (0-10) how painful the cannulation was experienced. Assessed once a week.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust, Sykehuset Innlandet HF, Kristiansund Hospital, Bodø sykehus, University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Stein Hallan, PhD MD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536548
- Sponsor's protocol ID
- 2011/2544
- Status last verified
- Sep 2020
- First submitted
- 16 Feb 2012
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rønning MI, Benshop P , Hallan S. Direction and angle-assisted cannulation of AV-fistula in hemodialysis patients - a rancomized controlled study. 2016; Oral presentation for the Vascular Access Society of America, Chicago 2016, abstract 1.1.4.8
Ronning MI, Benschop WP, Ovrehus MA, Hultstrom M, Hallan SI. Direction- and Angle-Assisted Buttonhole Cannulation of Arteriovenous Fistula in Hemodialysis Patients: A Multicenter Randomized Controlled Trial. Kidney Med. 2021 Dec 1;4(2):100393. doi: 10.1016/j.xkme.2021.10.006. eCollection 2022 Feb.
PubMed 35243305
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicating Direction and Angle for Button-hole Cannulating of AV-fistula in Hemodialysis Patients - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01536548
- Acronym / sponsor ID
- 2011/2544
- Conditions
- Chronic Kidney Disease, Kidney Failure
- Keywords
- hemodialysis, cannulation, AV-fistula, buttonhole technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust, Sykehuset Innlandet HF, Kristiansund Hospital, Bodø sykehus, University Hospital, Akershus
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Feb 2012 (estimated)
- 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.
Arteriovenous fistula is the preferred access for hemodialysis, and cannulation using a "button-hole" technique is increasingly recommended. By using the same two sites for cannulation there are reports of less risk of complications and less pain for the patient. However, button-hole cannulation can be difficult for the dialysis nurse, and failing cannulations can damage the AV fistula and increase patient discomfort. The investigators therefore will test whether a simple marking on the skin of the direction and angle of cannulation used in each specific patient could improve the probability of a successful and painfree cannulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin drawing | Experimental | Procedure: Skin drawing |
| No skin drawing | Active comparator | Procedure: No skin drawing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic kidney disease
- hemodialysis
- arteriovenous fistula
- established buttonhole technique
- informed consent signed
Key exclusion criteria (4 listed)
- child
- minor
- not speaking Norwegian
- not willing to sign 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 |
|---|---|---|
| Skin drawingMark direction and angle for cannulation with a pencil on the skin | Procedure or surgery | Skin drawing |
| No skin drawingStandard practice; i.e. no marks on skin to help find correct direction and angle for introducing needles | Procedure or surgery | No skin drawing |
Primary outcome
Percentage of successful cannulations
Time frame: 8 weeks
A successful cannulation is defined as being able to insert a blunt needle in both canals at the first attempt.
3 secondary outcomes
Difficulty of cannulation
Time frame: 8 weeks
Fear of cannulation
Time frame: 8 weeks
Pain at cannulation
Time frame: 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 5 Oct 2020.
- BackgroundRønning MI, Benshop P , Hallan S. Direction and angle-assisted cannulation of AV-fistula in hemodialysis patients - a rancomized controlled study. 2016; Oral presentation for the Vascular Access Society of America, Chicago 2016, abstract 1.1.4.8
- Derived from this study: PubMed 35243305Ronning MI, Benschop WP, Ovrehus MA, Hultstrom M, Hallan SI. Direction- and Angle-Assisted Buttonhole Cannulation of Arteriovenous Fistula in Hemodialysis Patients: A Multicenter Randomized Controlled Trial. Kidney Med. 2021 Dec 1;4(2):100393. doi: 10.1016/j.xkme.2021.10.006. eCollection 2022 Feb.
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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.
Stein Hallan, PhD MD study director
Norwegian University of Science and Technology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin drawing and No skin drawing in people with Chronic Kidney Disease and Kidney Failure, run by Norwegian University of Science and Technology at 8 sites in Norway.
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 5 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 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Norway. 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?
Percentage of successful cannulations (time frame: 8 weeks). 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 NCT01536548, which also lists 2 linked publications.
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 5 Oct 2020.