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Venous Site for Central Catheterization (3SITES)

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ClinicalTrials.gov Identifier: NCT01479153
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Critical Care Catheterization ICU Procedure: Randomization of the site for catheterization

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial
Study Start Date : October 2011
Primary Completion Date : November 2014
Study Completion Date : February 2015
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Subclavian catheterization Procedure: Randomization of the site for catheterization
Ultra-sound guided insertion strongly recommended
Active Comparator: Internal Jugular catheterization Procedure: Randomization of the site for catheterization
Ultra-sound guided insertion strongly recommended
Active Comparator: Femoral Catheterization Procedure: Randomization of the site for catheterization
Ultra-sound guided insertion strongly recommended


Outcome Measures

Primary Outcome Measures :
  1. Major complications including catheter-related bloodstream infection [ Time Frame: From central catheter insertion to 48-h after removal ]
    Catheter-related bloodstream infection: (positive catheter-tip quantitative culture plus positive peripheral blood culture(s))


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient admitted in the Intensive Care Unit
  • Requiring Central Venous Catheterization

Exclusion Criteria:

  • Patients with only one site available
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479153


Locations
France
Medical Intensive Care Unit, CHU Caen
Caen, France, 14000
Surgical Intensive Care Unit, CHU Caen
Caen, France, pottier-v@chu-caen.fr
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, France
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Jean-Jacques Parienti, MD, PhD CHU Caen