3SITES: Venous Site for Central Catheterization

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01479153
• Collaborator: (none)
• Enrollment: 3,471
• Locations: 5
• Arms: 3
• Duration (Months): 40
• Patients Per Site: 694.2
• Patients Per Site Per Month: 17.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Critical Care; Catheterization; ICU	Procedure: Randomization of the site for catheterization	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3471 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Major complications including catheter-related bloodstream infection [From central catheter insertion to 48-h after removal]

   Catheter-related bloodstream infection: (positive catheter-tip quantitative culture plus positive peripheral blood culture(s))

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient admitted in the Intensive Care Unit

• Requiring Central Venous Catheterization

Exclusion Criteria:

• Patients with only one site available

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Intensive Care Unit, CHU Caen	Caen		France	14000
2	Surgical Intensive Care Unit, CHU Caen	Caen		France	[e-mail]
3	Medical Intensive Care Unit, Cochin, AP-HP	Paris		France
4	Médical Intensive Care Unit, Lariboisière, AP-HP	Paris		France
5	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT01479153
• Other Study ID Numbers: ID RCB 2010-A00813-36
• First Posted: Nov 24, 2011
• Last Update Posted: Aug 23, 2016
• Last Verified: Jul 1, 2015

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

Study Results

No Results Posted as of Aug 23, 2016