NCT00485992

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 21, 2011

Status Verified

January 1, 2008

Enrollment Period

4 months

First QC Date

June 12, 2007

Last Update Submit

November 18, 2011

Conditions

Keywords

blood stream infectionCICUpediatricchlorhexidine swabs

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Patients in Children's Healthcare of Atlanta, Egleston, in CICU between 8.1.06 to 12.31.06

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Nicole M Jarrell, RNC, MSN

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 13, 2007

Study Start

August 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2007

Last Updated

November 21, 2011

Record last verified: 2008-01

Locations