Semi-blunt Needles: is Outcome Better?

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00840372
First received: February 9, 2009
Last updated: September 28, 2009
Last verified: September 2009
  Purpose

The aim of this observational study in patients chronically hemodialyzed by a native arterio-venous fistula is to determine the impact of the use of semi-blunt needles on the quality of the punction. The investigators have observed that cannulation with blunt needles (button-hole method) is sometimes difficult and the use of a sharp needle may be necessary, with consequently more hematomes and infections. Our hypothesis is that canulation with semi-blunt needles would be easier than with classical blunt needles, and consequently the use of sharp needles would become less frequent.

Inclusion criteria and study design are detailed below.


Condition Intervention
Chronic Hemodialysis Patients
Vascular Abord: Native Arterio-venous Fistula
Buttonhole Cannulation
Procedure: Buttonhole cannulation with semi-blunt needles

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Incidence of AVF hematomes [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Incidence of use of sharp needles [ Time Frame: Two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of trampoline-effect [ Time Frame: Two months ] [ Designated as safety issue: No ]
  • Incidence of AVF infections [ Time Frame: Two months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Chronic hemodialysis patients, native arterio-venous fistula
Procedure: Buttonhole cannulation with semi-blunt needles
Use of semi-blunt needles, compared to blunt needles, at every dialysis session
Other Name: Buttonhole cannulation with semi-blunt needles
2
Chronic hemodialysis patients, native arterio-venous fistula
Procedure: Buttonhole cannulation with semi-blunt needles
Use of semi-blunt needles, compared to blunt needles, at every dialysis session
Other Name: Buttonhole cannulation with semi-blunt needles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic hemodialysis patients dialyzed in Cliniques Universitaires Saint-Luc by a native arterio-venous fistula

Criteria

Inclusion Criteria:

  • Chronic hemodialysis patients
  • Aged 18 years or more
  • Dialyzed by a native arterio-venous fistula
  • Cannuled by buttonhole method with blunt needles

Exclusion Criteria:

  • Acute hemodialysis
  • Puncture with 14G needles
  • Puncture with a sole needle
  • Arterio-venous grafts
  • Patients transferred from another centre
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00840372

Locations
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Laura Labriola, M.D. Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Laura LABRIOLA, M.D., Cliniques Universitaires Saint-Luc, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00840372     History of Changes
Other Study ID Numbers: Needles, Semi-blunt needles
Study First Received: February 9, 2009
Last Updated: September 28, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Blunt needles
Semi-blunt needles
Buttonhole cannulation method

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 31, 2014