Semi-blunt Needles: is Outcome Better?

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT00840372
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hemodialysis Patients; Vascular Abord: Native Arterio-venous Fistula; Buttonhole Cannulation	Procedure: Buttonhole cannulation with semi-blunt needles

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Incidence of AVF hematomes [Two months]

2. Incidence of use of sharp needles [Two months]

Secondary Outcome Measures

1. Incidence of trampoline-effect [Two months]

2. Incidence of AVF infections [Two months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00840372
• Other Study ID Numbers: Needles; Semi-blunt needles
• First Posted: Feb 10, 2009
• Last Update Posted: Sep 29, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Blunt needles; Semi-blunt needles; Buttonhole cannulation method
• Additional relevant MeSH terms: Arteriovenous Fistula; Fistula

Study Results

No Results Posted as of Sep 29, 2009