NCT00122707

Brief Summary

The purpose of this study is to compare the mechanical and infectious complications of peripheral versus central venous catheters in critically ill patients. Group allocation will be performed by randomization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

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

April 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

March 22, 2006

Status Verified

June 1, 2005

First QC Date

July 19, 2005

Last Update Submit

March 21, 2006

Conditions

Keywords

catheter-related infectionmechanical complications of catheters

Outcome Measures

Primary Outcomes (3)

  • failure to insert line

  • mechanical complications of intravenous line insertion

  • infectious complications of intravenous lines

Secondary Outcomes (1)

  • number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)

Interventions

cathetersDEVICE

Eligibility Criteria

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

You may qualify if:

  • Patients requiring low to moderate doses of continuous catecholamine administration in the ICU
  • Patients with 2 failed attempts at inserting a peripheral line
  • Patients who require daily change of lines

You may not qualify if:

  • Patients aged less than 18 years
  • Pregnancy
  • Absolute necessity of central venous access (refractory shock/high dose catecholamine infusion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation, Hopital Louis Mourier

Colombes, 92700, France

Location

Related Publications (4)

  • Timsit JF. [Updating of the 12th consensus conference of the Societe de Reanimation de langue francaise (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. doi: 10.1016/j.annfar.2004.12.022. French.

    PMID: 15792575BACKGROUND
  • Polderman KH, Girbes AJ. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med. 2002 Jan;28(1):1-17. doi: 10.1007/s00134-001-1154-9. Epub 2001 Dec 4.

    PMID: 11818994BACKGROUND
  • Polderman KH, Girbes AR. Central venous catheter use. Part 2: infectious complications. Intensive Care Med. 2002 Jan;28(1):18-28. doi: 10.1007/s00134-001-1156-7. Epub 2001 Nov 29.

    PMID: 11818995BACKGROUND
  • Ricard JD, Salomon L, Boyer A, Thiery G, Meybeck A, Roy C, Pasquet B, Le Miere E, Dreyfuss D. Central or peripheral catheters for initial venous access of ICU patients: a randomized controlled trial. Crit Care Med. 2013 Sep;41(9):2108-15. doi: 10.1097/CCM.0b013e31828a42c5.

MeSH Terms

Conditions

Respiratory InsufficiencyShockComaCatheter-Related Infections

Interventions

Catheters

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsInfections

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Jean-Damien Ricard, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

April 1, 2004

Study Completion

October 1, 2005

Last Updated

March 22, 2006

Record last verified: 2005-06

Locations