Semi-blunt Needles: is Outcome Better? (Needles)

September 28, 2009 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of AVF hematomes
Time Frame: Two months
Two months
Incidence of use of sharp needles
Time Frame: Two months
Two months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of trampoline-effect
Time Frame: Two months
Two months
Incidence of AVF infections
Time Frame: Two months
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Laura Labriola, M.D., Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

September 29, 2009

Last Update Submitted That Met QC Criteria

September 28, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Needles
  • Semi-blunt needles

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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