Semi-blunt Needles: is Outcome Better?

Chronic Hemodialysis Patients Clinical Trial

— Needles  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840372
• Other study ID #: Needles
• Secondary ID: Semi-blunt needl
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: September 28, 2009
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2009
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Buttonhole Cannulation
• Chronic Hemodialysis Patients
• Vascular Abord: Native Arterio-venous Fistula

Intervention

Procedure:
• Buttonhole cannulation with semi-blunt needles
Use of semi-blunt needles, compared to blunt needles, at every dialysis session

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AVF hematomes		Two months	No
Primary	Incidence of use of sharp needles		Two months	No
Secondary	Incidence of trampoline-effect		Two months	No
Secondary	Incidence of AVF infections		Two months	No