Comparison of Central and Peripheral Venous Catheters

Respiratory Insufficiency Clinical Trial

Official title:

Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122707
• Other study ID #: LMR1
• Status: Completed
• Phase: N/A
• First received: July 19, 2005
• Last updated: March 21, 2006
• Start date: April 2004
• Est. completion date: October 2005

Study information

• Verified date: June 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coma
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Shock

Intervention

Device:
• catheters

Locations

Country	Name	City	State
France	Service de Réanimation, Hopital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Polderman KH, Girbes AJ. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med. 2002 Jan;28(1):1-17. Epub 2001 Dec 4. Review. — View Citation

Polderman KH, Girbes AR. Central venous catheter use. Part 2: infectious complications. Intensive Care Med. 2002 Jan;28(1):18-28. Epub 2001 Nov 29. Review. — View Citation

Timsit JF. [Updating of the 12th consensus conference of the Société de Réanimation de langue française (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure to insert line
Primary	mechanical complications of intravenous line insertion
Primary	infectious complications of intravenous lines
Secondary	number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)