- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485992
Chlorhexidine Swabs Effectiveness in Reducing Blood Stream Infections
Effectiveness of Utilizing Chlorhexidine Swabs for Accessing Lines and Results Impact on Catheter Related Blood Stream Infections in the Cardiac Intensive Care Unit
Children's Healthcare of Atlanta (Children's) is collaborating with Child Health Corporation of America (CHCA) in the nationwide effort to reduce catheter related blood stream infections (BSIs). "As well as the human cost, central venous catheter related bloodstream infections significantly inflate hospital costs, mainly through increased length of stay in hospital, particularly in intensive care" (Jones, 2006).
The Cardiac Intensive Care Unit (CICU) is participating in this initiative by implementing the BSI "Bundles" per the CHCA guidelines. BSI "bundles" are a group of patient care practices designed to reduce BSI infection rates with implementation in patient care areas. The bundles include recommendations for central line maintenance including line insertion, dressing changes, line accesses, and monitoring for medical necessity. These bundles were implemented on January 16, 2006, when the BSI rate in the CICU had peaked at 18.2 (rate of infections per 1000 catheter days). The BSI rates historically for the past two years have been highly variable (see attached graph for data from Jan. 04 through Oct. 06). The target goal is to maintain a rate below 3.7 which has only been realized twice since the January BSI bundle implementation.
Current practice for the care of central lines outlined in the BSI Bundles is based on the Centers for Disease Control and Prevention (CDC) guidelines published in 2002. These guidelines included important changes to practice involving the use of chlorhexidine (CHG) containing products for improved infection prevention. CHG solutions are currently available as either 2% or 3.15% chlorhexidine gluconate in a 70% isopropyl alcohol solution.
The Primary Aim is to determine if CHG is effective as an antiseptic wipe for accessing lines to draw blood and administer medications. Compare the effectiveness of CHG containing alcohol wipes (3.15% CHG/70% isopropyl alcohol) to plain alcohol in order to determine best practice for the CICU.
Study Overview
Status
Conditions
Detailed Description
Children's Healthcare of Atlanta (Children's) is collaborating with Child Health Corporation of America (CHCA) in the nationwide effort to reduce catheter related blood stream infections (BSIs).
The Cardiac Intensive Care Unit (CICU) is participating in this initiative by implementing the BSI "Bundles" per the CHCA guidelines. BSI "bundles" are a group of patient care practices designed to reduce BSI infection rates with implementation in patient care areas.
Multiple risk factors are assumed to contribute to the high risk and rate of infection in the CICU patient population.
Many risk factors cannot be controlled, such as patient age, weight, diagnosis, etc. Hence the controllable risk factors are the focus for reducing BSI rates, primarily related to the care of central lines. This is the main focus of the BSI Bundles which are aimed at reducing the risks associated with the utilization of central lines.
The primary aim is to determine if CHG is effective as an antiseptic wipe for accessing lines to draw blood and administer medications. Compare the effectiveness of CHG containing alcohol wipes (3.15% CHG/70% isopropyl alcohol) to plain alcohol in order to determine best practice for the CICU.
The secondary aim is to reduce BSI rates in the CICU patient population, improving patient care outcomes and reducing costs of hospitalization by the resulting reduction and prevention of expected BSIs.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30329
- Children's healthcare of Atlanta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients in Children's Healthcare of Atlanta, Egleston, in CICU between 8.1.06 to 12.31.06
Exclusion Criteria:
- those who do not qualify under inclusion criteria.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicole M Jarrell, RNC, MSN, Children's healthcare of Atlanta
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-201
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