Clinical trial NCT00122707: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Shock
Coma
Keywords: catheter-related infection
mechanical complications of catheters
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: failure to insert line
measure: mechanical complications of intravenous line insertion
measure: infectious complications of intravenous lines
Secondary outcomes:
measure: number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)
Other outcomes:
Locations:
city: Colombes
country: France
facility: Service de Réanimation, Hopital Louis Mourier
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Damien Ricard, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.