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

December 17, 2011 updated by: Bert Bammens, Universitaire Ziekenhuizen KU Leuven

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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  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. Ropeladder 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Bert RM Bammens, MD, PhD, University Hospital Gasthuisberg Leuven, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 15, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

December 20, 2011

Last Update Submitted That Met QC Criteria

December 17, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S50619

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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