Study of the Use of Coated Venous Catheters in the Critically Ill Child

Completed · Phase 4

Conditions studied: Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter

In brief

This study should help determine to determine whether or not the use of an antibiotic coated catheter will significantly reduce the number of central line related bloodstream infections in children requiring a CVC. This study may also determine if antibiotic coated catheters will be significantly less likely than non-antibiotic coated catheters to allow bacteria to live (colonize) in/on the catheter. The use of central venous catheters (CVC) is paramount to the care of critically ill children. Thus, in the pediatric intensive care unit (PICU), these catheters are widely used in situations when more than peripheral venous access is necessary. This central access allows the delivery of fluids, e.g, blood, medications, etc. as well as serves as a means to withdraw blood. It has been estimated that more than 250,000 nosocomial bloodstream infections occur each year, with 90% of these associated with the use of CVCs. More recently, the National Nosocomial Infection Surveillance System (NNIS) reported during 1992-2001 CVC-associated bloodstream infections (BSI) in ICU settings occurred at rates of 2.9-11.3 BSI per 1,000 catheter days. The cost of treating CVC related BSI has been estimated to be in excess of $28,000 per catheter. In the adult medical literature, there is strong evidence supporting use of antiseptic or antibiotic coated catheters to reduce the cost of hospitalization for CVC related infections. Cost-benefit studies have suggested that if the baseline incidence of CVC BSI is \>0.4 BSI per 1000 catheter days, $59,000 will be saved, 7 cases of BSI will be avoided, and 1 death prevented for every 300 anti-septic impregnated CVCs used.

Key facts

Study ID
NCT00202813
Run by
Corewell Health West
People needed
500
Starts
2003-07-01
Expected to finish
2005-10-01
Last updated by the study team
2024-04-08

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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