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Clinical Trials/NCT00548132
NCT00548132
Completed
Phase 4

Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)

Washington University School of Medicine1 site in 1 country1,088 target enrollmentFebruary 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Catheter-related Bloodstream Infection
Sponsor
Washington University School of Medicine
Enrollment
1088
Locations
1
Primary Endpoint
The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.

Detailed Description

At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
May 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).

Exclusion Criteria

  • patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.

Outcomes

Primary Outcomes

The Number of Catheter Related Bloodstream Infections (BSI) /1000 Catheter Days in Both Arms

Time Frame: 2 years

The outcome measure is the number of episodes of bloodstream infections (BSI) divided by the catheter days at risk multiplied by 1000 for standardization

Secondary Outcomes

  • Clinical Sepsis Episodes/Per 1000 Catheter Days(2 years)

Study Sites (1)

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