Semi-blunt Needles: is Outcome Better? | NCT00840372

Studies
Semi-blunt Needles: is Outcome Better?

NCT00840372

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Sep 29, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

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

Interventions

Buttonhole cannulation with semi-blunt needles

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Semi-blunt needles

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Feb 9, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2009

Last Update Posted Date

Sep 29, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Chronic hemodialysis patients, native arterio-venous fistula	Procedure: Buttonhole cannulation with semi-blunt needles
2		Chronic hemodialysis patients, native arterio-venous fistula	Procedure: Buttonhole cannulation with semi-blunt needles

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buttonhole cannulation with semi-blunt needles	Procedure	Use of semi-blunt needles, compared to blunt needles, at every dialysis session	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laura Labriola, M.D.	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint Luc		Brussels		1200	Belgium