Trial Review

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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 information initially 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] 286028 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital-acquired bloodstream infections 294001 0
Condition category
Condition code
Infection 294298 294298 0 0
Studies of infection and infectious agents
Public Health 294361 294361 0 0
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] 291011 0
Treatment: Other
Intervention code [2] 291056 0
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] 294103 0
Incidence of acquired blood stream infections.
Timepoint [1] 294103 0
Microbiological confirmation of acquired blood stream infections that occur during the critically ill patients admission to the intensive care unit.
Secondary outcome [1] 312510 0
Incidence of Multi-Resistant Staphylococcus Aureus (MRSA)
Timepoint [1] 312510 0
Swab-based MRSA isolates collected during the critically ill patients admission to the intensive care unit.
Secondary outcome [2] 312511 0
Incidence of gram negative bacteria
Timepoint [2] 312511 0
Swab-based gram negative bacteria isolates collected during the critically ill patients admission to the intensive care unit.
Secondary outcome [3] 312512 0
Incidence of multi-resistant gram negative bacteria
Timepoint [3] 312512 0
Microbiological confirmation of all multi-resistant gram negative bacteria isolates collected during the 12 month observation periods.
Secondary outcome [4] 312513 0
Incidence of respiratory tract MRSA
Timepoint [4] 312513 0
Microbiological confirmation of MRSA isolates from respiratory tract samples collected during the 12 month observation periods.
Secondary outcome [5] 312514 0
Incidence of respiratory tract gram negative bacteria
Timepoint [5] 312514 0
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?
No
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] 3357 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9136 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290620 0
Hospital
Name [1] 290620 0
Austin Health
Country [1] 290620 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 289305 0
Individual
Name [1] 289305 0
Professor Rinaldo Bellomo
Director, Intensive Care Research
Address [1] 289305 0
Austin Health
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 289305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292249 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 292249 0
145 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 292249 0
Australia
Date submitted for ethics approval [1] 292249 0
14/01/2014
Approval date [1] 292249 0
04/02/2014
Ethics approval number [1] 292249 0
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] 284 284 0 0
/AnzctrAttachments/367814-LNR14Austin23 Audit Activity Approval 04Feb14.pdf

Contacts
Principal investigator
Name 54314 0
Prof Rinaldo Bellomo
Address 54314 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 54314 0
Australia
Phone 54314 0
+61 3 9496 5992
Fax 54314 0
+61 3 9496 3932
Email 54314 0
[email protected]
Contact person for public queries
Name 54315 0
Glenn Eastwood
Address 54315 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 54315 0
Australia
Phone 54315 0
+61 3 9496 4835
Fax 54315 0
+61 3 9496 3932
Email 54315 0
[email protected]
Contact person for scientific queries
Name 54316 0
Rinaldo Bellomo
Address 54316 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 54316 0
Australia
Phone 54316 0
+61 3 9496 5992
Fax 54316 0
+61 3 9496 3932
Email 54316 0
[email protected]

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

Documents added automatically
No additional documents have been identified.