Venous Site for Central Catheterization (3SITES)

August 22, 2016 updated by: University Hospital, Caen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3471

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Medical Intensive Care Unit, CHU Caen
      • Caen, France, pottier-v@chu-caen.fr
        • Surgical Intensive Care Unit, CHU Caen
      • Paris, France
        • Medical Intensive Care Unit, Cochin, AP-HP
      • Paris, France
        • Médical Intensive Care Unit, Lariboisière, AP-HP
      • Saint Lô, France
        • Polyvalent Intensive Care Unit, Mémorial France Etats-Unis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with only one site available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
From central catheter insertion to 48-h after removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Jean-Jacques Parienti, MD, PhD, CHU Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ID RCB 2010-A00813-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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