Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients
Primary Purpose
Dialysis, Fistula
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
catheter for AV fistula cannulation
Sponsored by
About this trial
This is an interventional treatment trial for Dialysis focused on measuring arteriovenous fistula, dialysis access, pain, anxiety, fistula related complications, aneurysm
Eligibility Criteria
Inclusion Criteria:
- chronic hemodialysis
- at least 18 years of age
- AV fistula for vascular access
- speaking the Dutch language
Exclusion Criteria:
- lack of informed consent
Sites / Locations
- University Hospital Gasthuisberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
A1
A2
B1
B2
Arm Description
Buttonhole cannulation technique
Rope ladder cannulation technique
Catheter with bevel point
Catheter with cylindrical point
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00544492
First Posted
October 15, 2007
Last Updated
December 17, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT00544492
Brief Title
Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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:
A. 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.
B. 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
A. 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.
B. 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:
A. 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.
B. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis, Fistula
Keywords
arteriovenous fistula, dialysis access, pain, anxiety, fistula related complications, aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Experimental
Arm Description
Buttonhole cannulation technique
Arm Title
A2
Arm Type
Active Comparator
Arm Description
Rope ladder cannulation technique
Arm Title
B1
Arm Type
Experimental
Arm Description
Catheter with bevel point
Arm Title
B2
Arm Type
Active Comparator
Arm Description
Catheter with cylindrical point
Intervention Type
Device
Intervention Name(s)
catheter for AV fistula cannulation
Other Intervention Name(s)
Beldico 1425 cath, Beldico 1425 mf cath, Beldico 1425 mf cath blunt
Intervention Description
catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic hemodialysis
at least 18 years of age
AV fistula for vascular access
speaking the Dutch language
Exclusion Criteria:
lack of informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bert RM Bammens, MD, PhD
Organizational Affiliation
University Hospital Gasthuisberg Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
17170544
Citation
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.
Results Reference
background
PubMed Identifier
12234281
Citation
Allon 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.
Results Reference
background
PubMed Identifier
16623674
Citation
Marticorena 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.
Results Reference
background
PubMed Identifier
16859201
Citation
Ball LK. The buttonhole technique for arteriovenous fistula cannulation. Nephrol Nurs J. 2006 May-Jun;33(3):299-304.
Results Reference
background
PubMed Identifier
7984461
Citation
Lloyd G, McLauchlan A. Nurses' attitudes towards management of pain. Nurs Times. 1994 Oct 26-Nov 1;90(43):40-3.
Results Reference
background
PubMed Identifier
9839185
Citation
McDonald 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.
Results Reference
background
PubMed Identifier
12472802
Citation
Miller 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.
Results Reference
background
PubMed Identifier
9588381
Citation
The 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. Erratum In: J Am Gerriatr Soc 1998 Jul;46(7):913.
Results Reference
background
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Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients
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