Chlorhexidine Swabs Effectiveness in Reducing Blood Stream Infections

This study has been terminated.
(sufficient data has been collected for significant conclusion)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00485992
First received: June 12, 2007
Last updated: November 18, 2011
Last verified: January 2008
  Purpose

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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Effectiveness of Utilizing Chlorhexidine Swabs for Accessing Lines and Results Impact on Catheter Related Blood Stream Infections in the Cardiac Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 352
Study Start Date: August 2006
Study Completion Date: December 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will observe from all children admitted to Children's CICU between 8.1.06 to 12.31.06; including both medical and surgical service patients.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485992

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Nicole M Jarrell, RNC, MSN Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Director Research, Children's Healthcare of Atlanta Institutional Review Board
ClinicalTrials.gov Identifier: NCT00485992     History of Changes
Other Study ID Numbers: 06-201
Study First Received: June 12, 2007
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
blood stream infection
CICU
pediatric
chlorhexidine swabs

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 21, 2014