DialysisPhase 4NCT00544492
Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients
A Phase 4 study testing catheter for AV fistula cannulation in people with Dialysis and Fistula, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A. Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique. B. Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- catheter for AV fistula cannulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2007to Mar 2010
- Phase
- Phase 4
- 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
- at least 18 years of age
- AV fistula for vascular access
- speaking the Dutch language
Who cannot join
- lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Pain, Anxiety, Complications Related to AV Fistula Cannulation in Chronic Hemodialysis Patients. A. Buttonhole vs. Rope Ladder Technique B. Catheters With Cylindrical Point vs. Catheters With Bevel Point in Rope Ladder Technique
- Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique.
- Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients.
The above background information gives rise to the following investigational questions:
Read more
- Buttonhole vs rope ladder technique
- Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique.
- Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique.
- Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: Bleeding time is shorter when using buttonhole technique versus rope ladder technique.
- Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique? Hypothesis: When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique.
- Rope ladder technique using catheters with cylindrical vs. bevel point
- Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point?
Hypothesis:
AV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.
Read the detailed description
- Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique. It was described for the first time as the "contant site method" by Twardowski et al. The authors report on a patient in whom the fistula was too short to use the rope ladder technique. As an alternative, the access was cannulated at a "constant site". Later, in 1984, Krönung used the name "buttonhole puncture technique". It was used primarily in patients treated with home hemodialysis, where cannulation was performed by one single person (often by the patient himself). In order to form a perfect buttonhole it is indeed essential that the fistula is cannulated at exactly the same site and using exactly the same angle every single time. The buttonhole technique has been adopted by the recent "National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) Guidelines" for vascular access. Studies show that patient pain scores and bleeding time after dialysis are positively influenced when using this cannulation technique.
- Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients.
The above background information gives rise to the following investigational questions:
- Buttonhole vs rope ladder technique
- Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique.
- Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique.
- Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: Bleeding time is shorter when using buttonhole technique versus rope ladder technique.
- Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique? Hypothesis: When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique.
- Ropeladder technique using catheters with cylindrical vs. bevel point
- Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point?
Hypothesis:
AV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.
- Being tested
- catheter for AV fistula cannulation
- Keywords
- arteriovenous fistula, dialysis access, pain, anxiety, fistula related complications, aneurysm
- Medical subject headings
- Fistula, Arteriovenous Fistula, Pain, Anxiety Disorders, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter for AV fistula cannulationDevice
Also called Beldico 1425 cath, Beldico 1425 mf cath, Beldico 1425 mf cath blunt
catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Buttonhole cannulation technique Receives: Device: catheter for AV fistula cannulation |
| A2 | Active comparator | Rope ladder cannulation technique Receives: Device: catheter for AV fistula cannulation |
| B1 | Experimental | Catheter with bevel point Receives: Device: catheter for AV fistula cannulation |
| B2 | Active comparator | Catheter with cylindrical point Receives: Device: catheter for AV fistula cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
A. Buttonhole vs. rope ladder AV fistula cannulation, comparison of pain, anxiety, bleeding time and fistula related complications B. Rope ladder AV fistula cannulation using catheters with cylindrical vs. bevel point, comparison of pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bert Bammens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Bert RM Bammens, MD, PhD, Principal investigator, University Hospital Gasthuisberg Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544492
- Sponsor's protocol ID
- S50619
- Status last verified
- Dec 2011
- First submitted
- 15 Oct 2007
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sands JJ. Increasing AV fistulae and decreasing dialysis catheters: two aspects of improving patient outcomes. Blood Purif. 2007;25(1):99-102. doi: 10.1159/000096404. Epub 2006 Dec 14.
PubMed 17170544Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.
PubMed 12234281Marticorena RM, Hunter J, Macleod S, Petershofer E, Dacouris N, Donnelly S, Goldstein MB. The salvage of aneurysmal fistulae utilizing a modified buttonhole cannulation technique and multiple cannulators. Hemodial Int. 2006 Apr;10(2):193-200. doi: 10.1111/j.1542-4758.2006.00094.x.
PubMed 16623674Ball LK. The buttonhole technique for arteriovenous fistula cannulation. Nephrol Nurs J. 2006 May-Jun;33(3):299-304.
PubMed 16859201Lloyd G, McLauchlan A. Nurses' attitudes towards management of pain. Nurs Times. 1994 Oct 26-Nov 1;90(43):40-3.
PubMed 7984461McDonald DD, Sterling R. Acute pain reduction strategies used by well older adults. Int J Nurs Stud. 1998 Oct;35(5):265-70. doi: 10.1016/s0020-7489(98)00039-x.
PubMed 9839185Miller CD, Robbin ML, Allon M. Gender differences in outcomes of arteriovenous fistulas in hemodialysis patients. Kidney Int. 2003 Jan;63(1):346-52. doi: 10.1046/j.1523-1755.2003.00740.x.
PubMed 12472802The management of chronic pain in older persons: AGS Panel on Chronic Pain in Older Persons. American Geriatrics Society. J Am Geriatr Soc. 1998 May;46(5):635-51. doi: 10.1111/j.1532-5415.1998.tb01084.x. No abstract available.
PubMed 9588381
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pain, Anxiety, Complications Related to AV Fistula Cannulation in Chronic Hemodialysis Patients. A. Buttonhole vs. Rope Ladder Technique B. Catheters With Cylindrical Point vs. Catheters With Bevel Point in Rope Ladder Technique
- ClinicalTrials.gov ID
- NCT00544492
- Acronym / sponsor ID
- S50619
- Keywords
- arteriovenous fistula, dialysis access, pain, anxiety, fistula related complications, aneurysm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Oct 2007 (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.
- Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique.
- Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients.
The above background information gives rise to the following investigational questions:
- Buttonhole vs rope ladder technique
- Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique.
- Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique.
- Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: Bleeding time is shorter when using buttonhole technique versus rope ladder technique.
- Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique? Hypothesis: When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique.
- Rope ladder technique using catheters with cylindrical vs. bevel point
- Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point?
Hypothesis:
AV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.
Detailed description
- Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique. It was described for the first time as the "contant site method" by Twardowski et al. The authors report on a patient in whom the fistula was too short to use the rope ladder technique. As an alternative, the access was cannulated at a "constant site". Later, in 1984, Krönung used the name "buttonhole puncture technique". It was used primarily in patients treated with home hemodialysis, where cannulation was performed by one single person (often by the patient himself). In order to form a perfect buttonhole it is indeed essential that the fistula is cannulated at exactly the same site and using exactly the same angle every single time. The buttonhole technique has been adopted by the recent "National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) Guidelines" for vascular access. Studies show that patient pain scores and bleeding time after dialysis are positively influenced when using this cannulation technique.
- Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients.
The above background information gives rise to the following investigational questions:
- Buttonhole vs rope ladder technique
- Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique.
- Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique.
- Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: Bleeding time is shorter when using buttonhole technique versus rope ladder technique.
- Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique? Hypothesis: When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique.
- Ropeladder technique using catheters with cylindrical vs. bevel point
- Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point?
Hypothesis:
AV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Device: catheter for AV fistula cannulationButtonhole cannulation technique |
| A2 | Active comparator | Device: catheter for AV fistula cannulationRope ladder cannulation technique |
| B1 | Experimental | Device: catheter for AV fistula cannulationCatheter with bevel point |
| B2 | Active comparator | Device: catheter for AV fistula cannulationCatheter with cylindrical point |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic hemodialysis
- at least 18 years of age
- AV fistula for vascular access
- speaking the Dutch language
Key exclusion criteria (1 listed)
- lack of 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 |
|---|---|---|
| catheter for AV fistula cannulationAlso: Beldico 1425 cath, Beldico 1425 mf cath, Beldico 1425 mf cath bluntcatheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point) | Device | A1, A2, B1, B2 |
Primary outcome
A. Buttonhole vs. rope ladder AV fistula cannulation, comparison of pain, anxiety, bleeding time and fistula related complications B. Rope ladder AV fistula cannulation using catheters with cylindrical vs. bevel point, comparison of pain
Time frame: 6 months
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 20 Dec 2011.
- Background: PubMed 17170544Sands JJ. Increasing AV fistulae and decreasing dialysis catheters: two aspects of improving patient outcomes. Blood Purif. 2007;25(1):99-102. doi: 10.1159/000096404. Epub 2006 Dec 14.
- Background: PubMed 12234281Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.
- Background: PubMed 16623674Marticorena RM, Hunter J, Macleod S, Petershofer E, Dacouris N, Donnelly S, Goldstein MB. The salvage of aneurysmal fistulae utilizing a modified buttonhole cannulation technique and multiple cannulators. Hemodial Int. 2006 Apr;10(2):193-200. doi: 10.1111/j.1542-4758.2006.00094.x.
- Background: PubMed 16859201Ball LK. The buttonhole technique for arteriovenous fistula cannulation. Nephrol Nurs J. 2006 May-Jun;33(3):299-304.
- Background: PubMed 7984461Lloyd G, McLauchlan A. Nurses' attitudes towards management of pain. Nurs Times. 1994 Oct 26-Nov 1;90(43):40-3.
- Background: PubMed 9839185McDonald DD, Sterling R. Acute pain reduction strategies used by well older adults. Int J Nurs Stud. 1998 Oct;35(5):265-70. doi: 10.1016/s0020-7489(98)00039-x.
- Background: PubMed 12472802Miller CD, Robbin ML, Allon M. Gender differences in outcomes of arteriovenous fistulas in hemodialysis patients. Kidney Int. 2003 Jan;63(1):346-52. doi: 10.1046/j.1523-1755.2003.00740.x.
- Background: PubMed 9588381The management of chronic pain in older persons: AGS Panel on Chronic Pain in Older Persons. American Geriatrics Society. J Am Geriatr Soc. 1998 May;46(5):635-51. doi: 10.1111/j.1532-5415.1998.tb01084.x. No abstract available.
Related trials for Dialysis
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
RecruitingObservational study
Il Registro Italiano di Dialisi Pediatrica (RIDP) - Italian Registry of Pediatric Dialysis
Dialysis, Kidney Transplantation
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Bert RM Bammens, MD, PhD principal investigator
University Hospital Gasthuisberg Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing catheter for AV fistula cannulation in people with Dialysis and Fistula, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 1 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 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
A. Buttonhole vs. rope ladder AV fistula cannulation, comparison of pain, anxiety, bleeding time and fistula related complications B. Rope ladder AV fistula cannulation using catheters with cylindrical vs. bevel point, comparison of pain (time frame: 6 months). 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 NCT00544492, which also lists 8 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 20 Dec 2011.