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

NCT00202813 | Completed Phase 4

• 1 other identifier: 2003-104
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

CVC; central venous catheter; infection; bloodstream infection; catheter infection; pediatric; children; antibiotic impregnated catheters

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

Interventions

Cook Spectrum Pediatric Central Venous Catheter Anti-microbial Impregnated Polyurethane and Arrow Pediatric Central Venous Catheter DEVICE

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health West: lead
• Helen DeVos Children's Hospital: collaborator

Study Sites (1)

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Infections; Sepsis

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Fitzgerald, MD

  Helen DeVos Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Critical Care Physician

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

US (1)