Comparison of Central and Peripheral Venous Catheters
Primary Purpose
Respiratory Insufficiency, Shock, Coma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
catheters
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Insufficiency focused on measuring catheter-related infection, mechanical complications of catheters
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients aged less than 18 years Pregnancy Absolute necessity of central venous access (refractory shock/high dose catecholamine infusion)
Sites / Locations
- Service de Réanimation, Hopital Louis Mourier
Outcomes
Primary Outcome Measures
failure to insert line
mechanical complications of intravenous line insertion
infectious complications of intravenous lines
Secondary Outcome Measures
number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)
Full Information
NCT ID
NCT00122707
First Posted
July 19, 2005
Last Updated
March 21, 2006
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00122707
Brief Title
Comparison of Central and Peripheral Venous Catheters
Official Title
Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
5. Study Description
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.
Detailed Description
Critically ill patients require intravenous administration of fluids and drugs. This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances. No study prospectively compared the feasibility, merits and complications of the two possibilities (i.e., central or peripheral venous line). This study includes patients that can receive either a central or a peripheral line (see inclusion criteria): mainly patients receiving large amounts of fluid, moderate doses of catecholamines or of drugs that may cause venous injury. Patients are randomized to receive either a peripheral or a central venous catheter. Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Shock, Coma
Keywords
catheter-related infection, mechanical complications of catheters
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
catheters
Primary Outcome Measure Information:
Title
failure to insert line
Title
mechanical complications of intravenous line insertion
Title
infectious complications of intravenous lines
Secondary Outcome Measure Information:
Title
number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients aged less than 18 years
Pregnancy
Absolute necessity of central venous access (refractory shock/high dose catecholamine infusion)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Damien Ricard, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation, Hopital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
15792575
Citation
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.
Results Reference
background
PubMed Identifier
11818994
Citation
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.
Results Reference
background
PubMed Identifier
11818995
Citation
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.
Results Reference
background
PubMed Identifier
23782969
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of Central and Peripheral Venous Catheters
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