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NCT00202813 · ClinicalTrials.gov registry record · Phase 4
Study of the Use of Coated Venous Catheters in the Critically Ill Child
A Phase 4 study, sponsored by Corewell Health West.
- Completed
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
NCT00202813 is a Phase 4 study that has completed, run by Corewell Health West. The registered enrollment target is 500 participants.
The verdict
NCT00202813, a Phase 4 study, has completed, sponsored by Corewell Health West.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2003-07 |
| Est. Completion | 2005-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00202813
The ClinicalTrials.gov registry entry for NCT00202813 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health West, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter is the first listed.
NCT00202813 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00202813 about?
NCT00202813 is a clinical study titled "Study of the Use of Coated Venous Catheters in the Critically Ill Child". 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 le...
What is the current status of trial NCT00202813?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2003-07. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00202813?
The interventions under investigation include: Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter (DEVICE).
Who is sponsoring clinical trial NCT00202813?
This trial is sponsored by Corewell Health West, which has 38 total clinical trials registered on ClinicalTrials.gov.
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