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

NCT ID: NCT00202813

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-10-31

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helen DeVos Children's Hospital

OTHER

Sponsor Role: collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Robert Fitzgerald

Pediatric Critical Care Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

Helen DeVos Children's Hospital

Locations

DeVos Children's Hospital

Grand Rapids, Michigan, United States

Countries

United States

Other Identifiers

2003-104

Identifier Type: -

Identifier Source: org_study_id