NCT01479153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,471

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 23, 2016

Status Verified

July 1, 2015

Enrollment Period

3.1 years

First QC Date

November 22, 2011

Last Update Submit

August 22, 2016

Conditions

Critical CareCatheterizationICU

Keywords

Central venous catheterizationMajor complicationsInternal JugularFemoralSubclavian

Outcome Measures

Primary Outcomes (1)

  • Major complications including catheter-related bloodstream infection

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

    From central catheter insertion to 48-h after removal

Study Arms (3)

Subclavian catheterization

ACTIVE COMPARATOR
Procedure: Randomization of the site for catheterization

Internal Jugular catheterization

ACTIVE COMPARATOR
Procedure: Randomization of the site for catheterization

Femoral Catheterization

ACTIVE COMPARATOR
Procedure: Randomization of the site for catheterization

Interventions

Randomization of the site for catheterizationPROCEDURE

Ultra-sound guided insertion strongly recommended

Femoral CatheterizationInternal Jugular catheterizationSubclavian catheterization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with only one site available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medical Intensive Care Unit, CHU Caen

Caen, 14000, France

Location

Surgical Intensive Care Unit, CHU Caen

Caen, pottier-v@chu-caen.fr, France

Location

Medical Intensive Care Unit, Cochin, AP-HP

Paris, France

Location

Médical Intensive Care Unit, Lariboisière, AP-HP

Paris, France

Location

Polyvalent Intensive Care Unit, Mémorial France Etats-Unis

Saint-Lô, France

Location

Related Publications (4)

  • Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.

    PMID: 26398070RESULT

  • Pages J, Hazera P, Megarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study. Intensive Care Med. 2016 Sep;42(9):1418-26. doi: 10.1007/s00134-016-4406-4. Epub 2016 Jun 16.

    PMID: 27311311RESULT

  • Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.

    PMID: 36645531DERIVED

  • Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

    PMID: 35799302DERIVED

MeSH Terms

Interventions

Catheterization

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Jean-Jacques Parienti, MD, PhD

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 24, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

August 23, 2016

Record last verified: 2015-07

Locations

FR(5)