Venous Site for Central Catheterization (3SITES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01479153
First received: November 22, 2011
Last updated: August 22, 2016
Last verified: July 2015
  Purpose

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 Intervention
Critical Care
Catheterization
ICU
Procedure: Randomization of the site for catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • 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))


Enrollment: 3471
Study Start Date: October 2011
Study Completion Date: February 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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