Venous Site for Central Catheterization (3SITES)

This study is currently recruiting participants.
Verified August 2012 by University Hospital, Caen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01479153
First received: November 22, 2011
Last updated: August 31, 2012
Last verified: August 2012
  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
Procedure: Randomization of the site for catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    Catheter-related bloodstream infection: (positive catheter-tip quantitative culture plus positive peripheral bloodculture(s))


Estimated Enrollment: 3333
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479153

Contacts
Contact: Jean-Jacques Dutheil, MS 33 2 31 06 53 51 dutheil-jj@chu-caen.fr
Contact: François Fournel, MS 33 2 31 06 54 88 fournel-f@chu-caen.fr

Locations
France
Medical Intensive Care Unit, CHU Caen Recruiting
Caen, France, 14000
Contact: Damien du Cheyron, MD, PhD       ducheyron-d@chu-caen.fr   
Contact: Cédric Daubin, MD       daubin-c@chu-caen.fr   
Sub-Investigator: Nicolas Terzi, MD, PhD         
Sub-Investigator: Romain Masson, MD         
Sub-Investigator: Amélie Séguin, MD         
Sub-Investigator: Xavier Valette, MD         
Principal Investigator: Damien du Cheyron, MD, PhD         
Principal Investigator: Cédric Daubin, MD         
Surgical Intensive Care Unit, CHU Caen Recruiting
Caen, France, pottier-v@chu-caen.fr
Contact: Véronique Pottier       pottier-v@chu-caen.fr   
Medical Intensive Care Unit, Cochin, AP-HP Recruiting
Paris, France
Contact: Nathalie Marin, PharmD       nathalie.marin@cch.aphp.fr   
Principal Investigator: Jean-Paul Mira, MD, PhD         
Sub-Investigator: Nicolas Mongardon, MD         
Médical Intensive Care Unit, Lariboisière, AP-HP Recruiting
Paris, France
Contact: Bruno Mégarbane, MD, PhD       bruno.megarbane@lrb.aphp.fr   
Polyvalent Intensive Care Unit, Mémorial France Etats-Unis Recruiting
Saint Lô, France
Contact: Pascal Hazera, MD       pascal.hazera@ch-stlo.fr   
Contact: Michel Ramakers, MD       michel.ramakers@ch-stlo.fr   
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Jean-Jacques Parienti, MD, PhD CHU Caen
  More Information

No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01479153     History of Changes
Other Study ID Numbers: ID RCB 2010-A00813-36
Study First Received: November 22, 2011
Last Updated: August 31, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés
France: Ministry of Health

Keywords provided by University Hospital, Caen:
Central venous catheterization
Major complications
Internal Jugular
Femoral
Subclavian

ClinicalTrials.gov processed this record on April 22, 2014