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

NCT00544492 | Completed Phase 4 DMC

• 1 other identifier: S50619
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

1. 1.Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique?
2. 2.Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique?
3. 3.Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique?
4. 4.Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique?
5. 5.Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point?

Conditions

Dialysis; Fistula

Keywords

arteriovenous fistula; dialysis access; pain; anxiety; fistula related complications; aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (4)

A1

EXPERIMENTAL

Buttonhole cannulation technique

Device: catheter for AV fistula cannulation

A2

ACTIVE COMPARATOR

Rope ladder cannulation technique

Device: catheter for AV fistula cannulation

B1

EXPERIMENTAL

Catheter with bevel point

Device: catheter for AV fistula cannulation

B2

ACTIVE COMPARATOR

Catheter with cylindrical point

Device: catheter for AV fistula cannulation

Interventions

catheter for AV fistula cannulation DEVICE

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

Also known as: Beldico 1425 cath, Beldico 1425 mf cath, Beldico 1425 mf cath blunt

A1; A2; B1; B2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic hemodialysis
• at least 18 years of age
• AV fistula for vascular access
• speaking the Dutch language

You may not qualify if:

• lack of informed consent

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (8)

• Sands JJ. Increasing AV fistulae and decreasing dialysis catheters: two aspects of improving patient outcomes. Blood Purif. 2007;25(1):99-102. doi: 10.1159/000096404. Epub 2006 Dec 14.

  PMID: 17170544 BACKGROUND

• Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.

  PMID: 12234281 BACKGROUND

• Marticorena RM, Hunter J, Macleod S, Petershofer E, Dacouris N, Donnelly S, Goldstein MB. The salvage of aneurysmal fistulae utilizing a modified buttonhole cannulation technique and multiple cannulators. Hemodial Int. 2006 Apr;10(2):193-200. doi: 10.1111/j.1542-4758.2006.00094.x.

  PMID: 16623674 BACKGROUND

• Ball LK. The buttonhole technique for arteriovenous fistula cannulation. Nephrol Nurs J. 2006 May-Jun;33(3):299-304.

  PMID: 16859201 BACKGROUND

• Lloyd G, McLauchlan A. Nurses' attitudes towards management of pain. Nurs Times. 1994 Oct 26-Nov 1;90(43):40-3.

  PMID: 7984461 BACKGROUND

• McDonald DD, Sterling R. Acute pain reduction strategies used by well older adults. Int J Nurs Stud. 1998 Oct;35(5):265-70. doi: 10.1016/s0020-7489(98)00039-x.

  PMID: 9839185 BACKGROUND

• Miller CD, Robbin ML, Allon M. Gender differences in outcomes of arteriovenous fistulas in hemodialysis patients. Kidney Int. 2003 Jan;63(1):346-52. doi: 10.1046/j.1523-1755.2003.00740.x.

  PMID: 12472802 BACKGROUND

• The management of chronic pain in older persons: AGS Panel on Chronic Pain in Older Persons. American Geriatrics Society. J Am Geriatr Soc. 1998 May;46(5):635-51. doi: 10.1111/j.1532-5415.1998.tb01084.x. No abstract available.

  PMID: 9588381 BACKGROUND

MeSH Terms

Conditions

Fistula; Arteriovenous Fistula; Pain; Anxiety Disorders; Aneurysm

Interventions

Catheters

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Bert RM Bammens, MD, PhD

  University Hospital Gasthuisberg Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 20, 2011

Record last verified: 2011-12

Locations

BE (1)