Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122707
Status:
COMPLETED
Last Update Posted:
2006-03-22
First Post:
2005-07-19
Brief Title:
Comparison of Central and Peripheral Venous Catheters
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None