CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
catheter for AV fistula cannulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00544492
NCT00544492Phase 4Completed

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

Universitaire Ziekenhuizen KU Leuven·interventional·Posted Oct 16, 2007·Updated Dec 20, 2011

In Brief

A Phase 4 clinical trial evaluating catheter for AV fistula cannulation for Dialysis and Fistula. Completed, enrolled 40 participants across 1 site.

Detailed 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 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDialysis, Fistula
CountriesBelgium
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 16, 2007
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.7 years ago

Interventions

catheter for AV fistula cannulationdevice

catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)