Comparison of Central and Peripheral Venous Catheters

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00122707
Collaborator
(none)
300
1
18
16.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: catheters
N/A

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).

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients
Study Start Date :
Apr 1, 2004
Study Completion Date :
Oct 1, 2005

Outcome Measures

Primary Outcome Measures

  1. failure to insert line []

  2. mechanical complications of intravenous line insertion []

  3. infectious complications of intravenous lines []

Secondary Outcome Measures

  1. number of cross-overs (due to impossibility of inserting/maintaining a peripheral line) []

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service de Réanimation, Hopital Louis Mourier Colombes France 92700

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean-Damien Ricard, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00122707
Other Study ID Numbers:
  • LMR1
First Posted:
Jul 22, 2005
Last Update Posted:
Mar 22, 2006
Last Verified:
Jun 1, 2005
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2006