Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dialysis Fistula |
Device: catheter for AV fistula cannulation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | October 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A1
Buttonhole cannulation technique
|
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)
Other Names:
|
|
Active Comparator: A2
Rope ladder cannulation technique
|
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)
Other Names:
|
|
Experimental: B1
Catheter with bevel 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)
Other Names:
|
|
Active Comparator: B2
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)
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| University Hospital Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Principal Investigator: | Bert RM Bammens, MD, PhD | University Hospital Gasthuisberg Leuven, Belgium |
More Information
Publications:
| Responsible Party: | Bert Bammens, MD, PhD, Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT00544492 History of Changes |
| Other Study ID Numbers: | S50619 |
| Study First Received: | October 15, 2007 |
| Last Updated: | December 17, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
arteriovenous fistula dialysis access pain |
anxiety fistula related complications aneurysm |
Additional relevant MeSH terms:
|
Anxiety Disorders Fistula Mental Disorders Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 13, 2013