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Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bert Bammens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00544492
First received: October 15, 2007
Last updated: December 17, 2011
Last verified: December 2011
  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

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

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 [ 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:
  • Beldico 1425 cath
  • Beldico 1425 mf cath
  • Beldico 1425 mf cath blunt
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:
  • Beldico 1425 cath
  • Beldico 1425 mf cath
  • Beldico 1425 mf cath blunt
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:
  • Beldico 1425 cath
  • Beldico 1425 mf cath
  • Beldico 1425 mf cath blunt
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:
  • Beldico 1425 cath
  • Beldico 1425 mf cath
  • Beldico 1425 mf cath blunt

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544492

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014