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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 15, 2007

Last Updated Date

June 4, 2008

Start Date ^†

October 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00544492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

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

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Dialysis
Fistula

Intervention ^†

Device: catheter for AV fistula cannulation

Study Arms / Comparison Groups

Experimental: Buttonhole cannulation technique
Active Comparator: Rope ladder cannulation technique
Experimental: Catheter with bevel point
Active Comparator: Catheter with cylindrical point

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2008

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Bert RM Bammens, MD, PhD

0032 16 344580

bert.bammens@uz.kuleuven.ac.be

Location Countries ^†

Belgium

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00544492

Responsible Party

Bert Bammens, MD, PhD, Department of Nephrology, University Hospitals Leuven, Belgium

Secondary IDs ^††

Study Sponsor ^†

Universitaire Ziekenhuizen Leuven

Collaborators ^††

Investigators ^†

Principal Investigator:

Bert RM Bammens, MD, PhD

University Hospital Gasthuisberg Leuven, Belgium

Information Provided By

Universitaire Ziekenhuizen Leuven

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.