ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000101583

Ethics application status

Approved

Date submitted

21/01/2015

Date registered

4/02/2015

Date last updated

20/05/2021

Date data sharing statement initially provided

25/11/2019

Date results provided

25/11/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evaluation of the effect of daily Chlorhexidine bathing on hospital-acquired infection for patients admitted to the intensive care unit

Scientific title

Universal Decolonization in ICU: A Before and After Audit to evaluate the effect of daily Chlorhexidine bathing on hospital-acquired infection for intensive care unit patients

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hospital-acquired bloodstream infections

Condition category

Condition code

Infection

Studies of infection and infectious agents

Public Health

Epidemiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

For a period of 12-months, at admission, and daily thereafter until discharge from ICU, critically ill patients admitted to the intensive care unit will have bathing performed using 2% chlorhexidine-impregnated washcloths.

Specifically, bathing will be completed according to manufacturer instructions. In brief, washcloths will be used in sequential order to rinse all body surfaces with the exception of the face during bathing with the 2% chlorhexidine-impregnated cloths in order to avoid exposure of the mucous membranes to the eyes and mouth. A manufacturer-produced video will be used to instruct nurses on the application of these cloths. Such washing will be applied within 4-6 hours of admission and, thereafter, daily at practically convenient times and at intervals no greater than 24 hours.

The adherence to the use of the 2% chlorhexidine-impregnated washcloths will be performed by medical record audit of medication use.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Comparator / control treatment

For the 12-month period preceedinig the introducing of bathing all critically ill patients admitted to the intenisve care unit.

Specifically, bathing during this period involved intensive care staff sequentially washing all body surfaces as they deemed appropriate using the available soaps, detergents and personal cleaning agents provided by the hospital. It was routine during this period to wash patients within 4-6 hours of admission and, thereafter, daily at practically convenient times and at intervals no greater than 24 hours.

Data collected for this period is from the Austin Hospital from March 2013 to February 2014.

Control group

Historical

Outcomes

Primary outcome [1]

Incidence of acquired blood stream infections.

Timepoint [1]

Microbiological confirmation of acquired blood stream infections that occur during the critically ill patients admission to the intensive care unit.

Secondary outcome [1]

Incidence of Multi-Resistant Staphylococcus Aureus (MRSA)

Timepoint [1]

Swab-based MRSA isolates collected during the critically ill patients admission to the intensive care unit.

Secondary outcome [2]

Incidence of gram negative bacteria

Timepoint [2]

Swab-based gram negative bacteria isolates collected during the critically ill patients admission to the intensive care unit.

Secondary outcome [3]

Incidence of multi-resistant gram negative bacteria

Timepoint [3]

Microbiological confirmation of all multi-resistant gram negative bacteria isolates collected during the 12 month observation periods.

Secondary outcome [4]

Incidence of respiratory tract MRSA

Timepoint [4]

Microbiological confirmation of MRSA isolates from respiratory tract samples collected during the 12 month observation periods.

Secondary outcome [5]

Incidence of respiratory tract gram negative bacteria

Timepoint [5]

Microbiological confirmation of all pathogenic gram negative bacteria from respiratory tract samples collected during the 12 month observation periods.

Eligibility

Key inclusion criteria

All patients admitted to the Austin Hospital ICU will be eligible for this audit.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Nil

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

This is a single group study as all participants receive the same intervention throughout the study.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Baseline comparisons will be performed using Fisher’s exact tests and reported as n (%). Continuous normally distributed variables will be compared using Student t-tests and reported as means (standard deviation), while non-normally distributed data will be compared using Wilcoxon rank-sum tests and reported as medians [interquartile range]. Changes over time will be determined using repeated measures mixed linear modeling with each patient treated as a random effect, and therapy group, time and the interaction of therapy group and time as effect fixed effects.

All analysis will be performed by using SPSS version 19.0 (SPSS Inc, Chicago, IL, USA).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2014

Actual

1/03/2014

Date of last participant enrolment

Anticipated

28/02/2015

Actual

31/03/2015

Date of last data collection

Anticipated

22/11/2019

Actual

31/12/2018

Sample size

Target

4400

Accrual to date

Final

4262

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

145 Studley Road
Heidelberg
Victoria 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo
Director, Intensive Care Research

Address [1]

Austin Health
145 Studley Road
Heidelberg
Victoria 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Road
Heidelberg
Victoria 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/01/2014

Approval date [1]

04/02/2014

Ethics approval number [1]

LNR/14/Austin/23

Summary

Brief summary

The aim of this study is to evaluate the impact of a change to universal patient decolonization in ICU based on emerging evidence.

Universal decolonization is the therapeutic administration of bathing with a chlorhexidine impregnated cloth daily to all ICU patients with the goal of decreasing hospital-acquired bloodstream infections and the acquisition of multidrug resistant organisms.  Recent studies have shown that such administration of daily chlorhexidine bathing to ICU patients is more effective than targeted decolonization or screening and isolation in reducing rates of MRSA clinical isolates and bloodstream infection from any pathogen.  

In response to these findings there is now consensus among ICU specialists, infectious diseases specialists and the Pharmacy Department that a policy of universal decolonization should be implemented in the Austin ICU beginning in early 2014.

Bathing will be completed according to manufacturer instructions. In brief, washcloths will be used in sequential order to rinse all body surfaces with the exception of the face during bathing with the 2% chlorhexidine-impregnated cloths in order to avoid exposure of the mucous membranes to the eyes and mouth. A manufacturer-produced video will be used to instruct nurses on the application of these cloths. Such washing will be applied within 4-6 hours of admission and, thereafter, daily at practically convenient times and at intervals no greater than 24 hours. 

Our primary outcome is the incidence of ICU acquired blood stream infections during the observation period.

All relevant data on patient characteristics, diagnoses and illness severity will continue to be collected as is routine in ICU.  All microbiological data will continue to be collected as is routine or clinically indicated in ICU.

Trial website

Trial related presentations / publications

Public notes

Trial registration has occured prior to completion and analysis of the study findings and after enrolment of the first participant into the trial.  The study was intervention was implemented based on strong evidence and was based on two large multicentre studies published in the New England Journal of Medicine.  The first by Climo et al (2009) and the second by Huang et al, 2014.  To provide a before period it was deemed appropriate to use data from March to February 2013-2014 and then have the after period be from February to March 2014-2015.

Attachments [1]

/AnzctrAttachments/367814-LNR14Austin23 Audit Activity Approval 04Feb14.pdf

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Glenn Eastwood

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Phone

+61 3 9496 4835

Fax

+61 3 9496 3932

glenn.eastwood@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

+61 3 9496 3932

rinaldo.bellomo@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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