Comparison of Central and Peripheral Venous Catheters
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Purpose
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 | Intervention |
|---|---|
|
Respiratory Insufficiency Shock Coma |
Device: catheters |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients |
- failure to insert line
- mechanical complications of intravenous line insertion
- infectious complications of intravenous lines
- number of cross-overs (due to impossibility of inserting/maintaining a peripheral line)
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | October 2005 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| France | |
| Service de Réanimation, Hopital Louis Mourier | |
| Colombes, France, 92700 | |
| Principal Investigator: | Jean-Damien Ricard, MD | Assistance Publique - Hôpitaux de Paris |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00122707 History of Changes |
| Other Study ID Numbers: | LMR1 |
| Study First Received: | July 19, 2005 |
| Last Updated: | March 21, 2006 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
catheter-related infection mechanical complications of catheters |
Additional relevant MeSH terms:
|
Respiratory Insufficiency Shock Respiration Disorders Respiratory Tract Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013