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

This study has been completed.
Sponsor:
Collaborator:
Helen DeVos Children's Hospital
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00202813
First received: September 13, 2005
Last updated: December 29, 2009
Last verified: December 2009

September 13, 2005
December 29, 2009
July 2003
October 2005   (final data collection date for primary outcome measure)
  • to determine if antibiotic coated catheters reduce the risk of catheter associated BSI in children hospitalized in PICU or in inpatient pediatric ward in comparison to non-antibiotic coated catheters.
  • An infection free interval is defined as beginning with the insertion of the cvc (or, if applicable with the cure of a infection in a catheter that was left in place anbd concluded with one of the outcomes listed
Same as current
Complete list of historical versions of study NCT00202813 on ClinicalTrials.gov Archive Site
  • to determine the bacterial pathogens associated with antibiotic coated CVC BSI and compare these pathogens with those normally associated with non-antibiotic coated CVC
  • To determine the bacterial pathogens associated with colonization of antibiotic coated catheter tips in comparison to those normally associated with non-antibiotic coated catheter tips.
  • To determine risk factors associated with CVC BSI
Same as current
Not Provided
Not Provided
 
Study of the Use of Coated Venous Catheters in the Critically Ill Child
The Use of Antibiotic-coated Venous Catheters in the Critically Ill Child: Reducing the Rate of Bloodstream Related Infections

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.

Catheter related infections are often difficult to treat because the pathogen may form a biofilm that actually embeds itself into the catheter material. Additionally, the catheter hub and skin around this area may be colonized with bacteria. It is by this route that pathogenic organisms migrate to the external surface of the catheter, which then can progress to the intravascular tip. To decrease the risk of CVC associated infections, antibiotic coated catheters have been used. Since 1990, several types of antiseptic or antimicrobial vascular catheters have been developed. These catheters are designed to protect both the external and internal surfaces of the device from colonization of certain bacteria. Raad et al, have demonstrated in a randomized multicenter clinical trial among hospitalized adult patients that CVCs coated with minocycline and rifampin significantly reduced the risk for catheter-related colonization and bloodstream infections[8]. However, there have been no clinical trials reported in the pediatric population on this issue. This study will prospectively compare in a randomized, blinded fashion the use of two Food & Drug Administration (FDA) approved central venous catheters - an antibiotic coated CVC to non-coated CVC at DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan. Additional major pediatric teaching hospitals may be added at a later time.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter
Device: Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

all patients ages 21 years or less admitted to the pediatric intensive care unit or general pediatric unit at DeVos Children's Hospital

research informed consent must be signed

Exclusion Criteria:

known allergy or sensitivity to minocycline, tetracyline, doxycycline, oxytetracycline, demeclocycline, rifampin, rifabutin

Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00202813
2003-104
Not Provided
Not Provided
Spectrum Health Hospitals
Helen DeVos Children's Hospital
Principal Investigator: Robert Fitzgerald, MD Helen DeVos Children's Hospital
Spectrum Health Hospitals
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP