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Sponsored by: |
Universitaire Ziekenhuizen Leuven |
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Information provided by: | Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT00544492 |
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
Hypothesis:
AV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.
Condition | Intervention | Phase |
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Dialysis Fistula |
Device: catheter for AV fistula cannulation |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Experimental
Buttonhole cannulation technique
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Device: catheter for AV fistula cannulation
catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
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A2: Active Comparator
Rope ladder cannulation technique
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Device: catheter for AV fistula cannulation
catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
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B1: Experimental
Catheter with bevel point
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Device: catheter for AV fistula cannulation
catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
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B2: Active Comparator
Catheter with cylindrical point
|
Device: catheter for AV fistula cannulation
catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bert RM Bammens, MD, PhD | 0032 16 344580 | bert.bammens@uz.kuleuven.ac.be |
Belgium | |
University Hospital Gasthuisberg | Recruiting |
Leuven, Belgium, 3000 |
Principal Investigator: | Bert RM Bammens, MD, PhD | University Hospital Gasthuisberg Leuven, Belgium |
Responsible Party: | Department of Nephrology, University Hospitals Leuven, Belgium ( Bert Bammens, MD, PhD ) |
Study ID Numbers: | S50619 |
Study First Received: | October 15, 2007 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00544492 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
arteriovenous fistula dialysis access pain |
anxiety fistula related complications aneurysm |
Pathological Conditions, Anatomical Aneurysm Arteriovenous Fistula Pain Fistula |