Venous Site for Central Catheterization (3SITES)

This study is currently recruiting participants. (see Contacts and Locations)
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
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

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 October 20, 2014