Venous Site for Central Catheterization (3SITES)
This study is currently recruiting participants.
Verified August 2012 by University Hospital, Caen
Sponsor:
University Hospital, Caen
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 21, 2013