Venous Site for Central Catheterization

Critical Care Clinical Trial

— 3SITES  

Official title:

Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479153
• Other study ID #: ID RCB 2010-A00813-36
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: August 22, 2016
• Start date: October 2011
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertésFrance: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.

The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3471
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient admitted in the Intensive Care Unit

• Requiring Central Venous Catheterization

Exclusion Criteria:

• Patients with only one site available

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheterization
• Critical Care
• ICU

Intervention

Procedure:
• Randomization of the site for catheterization
Ultra-sound guided insertion strongly recommended

Locations

Country	Name	City	State
France	Medical Intensive Care Unit, CHU Caen	Caen
France	Surgical Intensive Care Unit, CHU Caen	Caen
France	Medical Intensive Care Unit, Cochin, AP-HP	Paris
France	Médical Intensive Care Unit, Lariboisière, AP-HP	Paris
France	Polyvalent Intensive Care Unit, Mémorial France Etats-Unis	Saint Lô

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (2)

Pages J, Hazera P, Mégarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of — View Citation

Parienti JJ, Mongardon N, Mégarbane B, Mira JP, Kalfon P, Gros A, Marqué S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complications including catheter-related bloodstream infection	Catheter-related bloodstream infection: (positive catheter-tip quantitative culture plus positive peripheral blood culture(s))	From central catheter insertion to 48-h after removal	Yes

External Links

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