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Trial registered on ANZCTR
Registration number
ACTRN12618001693213
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
15/10/2018
Date last updated
16/03/2020
Date data sharing statement initially provided
16/03/2020
Date results information initially provided
16/03/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
A protocol to standardise intravenous fluid therapy after cardiac surgery
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Scientific title
Use of a mean systemic filling pressure analogue in ICU (Intensive Care Unit) patients post-cardiac surgery to guide fluid resuscitation and aim to reduce total amount of intravenous fluid administered until extubation.
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Secondary ID [1]
296283
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Nil known
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Universal Trial Number (UTN)
U1111-1221-9878
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post-cardiac surgery
309957
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Condition category
Condition code
Cardiovascular
308731
308731
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Introduction of a protocol to guide intravenous fluid resuscitation post cardiac surgery based on calculation of the "mean systemic filling pressure analogue" (Pmsa).
Before-and-after trial comparing data after introduction of protocol to previously collected (retrospective) data from an earlier quality assurance audit, with the aim to reduce the amount of IV fluid administered post-operatively.
Participants will be recruited upon arrival into the ICU immediately post-operatively. The Pmsa is calculated on arrival and then every 2 hours, or if the patient is not meeting MAP (mean arterial pressure) and CO (cardiac output) targets and the most recent Pmsa is more than 15 minutes old.
The Pmsa is calculated from use of a Swan-Ganz catheter and the below equation:
Pmsa = aCVP + bMAP + cCO
where a = 0.96, b = 0.04 and c is determined from patient anthropometrics (height and weight).
A spreadsheet will be loaded to the bedside computer with formulas for calculation, and at each time for calculation a CO will be measured by thermodilution using the Swan-Ganz catheter. The values for height, weight, MAP, CVP, and CO are entered into the spreadsheet to calculate Pmsa.
The Pmsa is calculated regularly to guide fluid management, and treating clinician's are advised to avoid further IV fluid boluses once the Pmsa is above 17 (based on previous studies showing a Pmsa of 17 or higher indicates fluid non-responsiveness).
This will be conducted by the bedside nurse and treating clinician (registrar/consultant) for each patient post-cardiac surgery in a tertiary ICU. Education will be provided on implementing the protocol and chart review will occur to determine compliance. Any consultants who do not wish to enrol a patient will be required to provide a reason for future inclusion/exclusion criteria.
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Intervention code [1]
312614
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Prevention
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Comparator / control treatment
The comparator is standard post-operative care where IV fluid administration is determined by the treating clinician without reference to the Pmsa.
This will be examined by a retrospective review of current standard care and amount of IV fluid administered (and relevant outcomes) over the past 12 months. (This is currently underway as part of an internal quality assurance project).
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Control group
Historical
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Outcomes
Primary outcome [1]
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Volume of IV fluid administered until extubation, which will be collected from bedside chart recording (hourly fluid input and cumulative total routinely recorded)
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Assessment method [1]
307720
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Timepoint [1]
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At time of extubation post-cardiac surgery
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Secondary outcome [1]
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Urine output
Collected from bedside chart (hourly urine output routinely recorded and cumulatively totaled)
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Assessment method [1]
352632
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Timepoint [1]
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Day 0, Day 1 and Day 2 post-operatively
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Secondary outcome [2]
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Plasma creatinine level
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Assessment method [2]
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Timepoint [2]
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Day 1 and Day 2 post-op
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Secondary outcome [3]
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Peak inotrope requirement (eg Adrenaline infusion, mcg/min)
Collected from bedside chart (routinely recorded)
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Assessment method [3]
352634
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Timepoint [3]
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From time of admission to time of extubation
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Secondary outcome [4]
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Time to extubation
-Collected from time of admission to time of extubation, which are both routinely recorded on the bedside chart
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Assessment method [4]
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Timepoint [4]
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From time of admission to time of extubation (both routinely recorded on bedside charts)
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Secondary outcome [5]
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Peak vasopressor requirement (eg Noradrenaline infusion, mcg/min)
Collected from bedside chart (routinely recorded)
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Assessment method [5]
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Timepoint [5]
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Over admission, from time of admission until time of extubation
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Eligibility
Key inclusion criteria
Elective cardiac surgery patients admitted to ICU post-operatively, including:
-Coronary Artery Bypass Graft Surgery
-Valve Surgery
-Combined Coronary Artery Bypass Graft and Valve Surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Emergency surgery
Pregnancy
Age less than 18 years old
Cardiac surgery involving the ascending aorta
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Other
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Other design features
A historical control group is being retrospectively analysed separately. The amount of fluid given via "standard-care" before introduction of the protocol will be determined, along with the above secondary outcomes based on bedside chart review.
Prospectively, eligible patients will be able to be recruited consecutively to this study protocol and then compared to the historical control group.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Analysis planned with multivariate analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/11/2018
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Actual
2/06/2019
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Date of last participant enrolment
Anticipated
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Actual
31/07/2019
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Date of last data collection
Anticipated
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Actual
30/09/2019
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12121
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
24290
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
300895
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Hospital
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Name [1]
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Monash Health - Monash Medical Centre
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Address [1]
300895
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Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
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Country [1]
300895
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Australia
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Primary sponsor type
Hospital
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Name
Monash Medical Centre
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Address
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
300439
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Justin Rheese
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Address [1]
300439
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Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Country [1]
300439
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Australia
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Other collaborator category [1]
280386
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Individual
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Name [1]
280386
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Adrian Pakavakis
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Address [1]
280386
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Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Country [1]
280386
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Australia
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Other collaborator category [2]
280387
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Individual
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Name [2]
280387
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William Geoffrey Parkin
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Address [2]
280387
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Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Country [2]
280387
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301650
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Monash Health HREC
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Ethics committee address [1]
301650
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Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Ethics committee country [1]
301650
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Australia
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Date submitted for ethics approval [1]
301650
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14/10/2018
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Approval date [1]
301650
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21/01/2019
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Ethics approval number [1]
301650
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Ethics committee name [2]
305603
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Monash Health HREC
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Ethics committee address [2]
305603
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Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Ethics committee country [2]
305603
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Australia
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Date submitted for ethics approval [2]
305603
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22/10/2018
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Approval date [2]
305603
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21/01/2019
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Ethics approval number [2]
305603
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44894
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Summary
Brief summary
The purpose of this study is to identify if introducing a protocol to standardise post-cardiac surgery fluid resuscitation can reduce the amount of intravenous fluid administered and potential patient harm.
By using a protocol and the calculated mean systemic filling pressure analogue, the amount of intravenous fluid received post-cardiac surgery can be restricted.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Justin Rheese
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Address
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Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Country
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Australia
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Phone
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+61 408435260
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Fax
87658
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Email
87658
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[email protected]
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Contact person for public queries
Name
87659
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Dr Justin Rheese
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Address
87659
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Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Country
87659
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Australia
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Phone
87659
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+61 408435260
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Fax
87659
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Email
87659
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[email protected]
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Contact person for scientific queries
Name
87660
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Dr Justin Rheese
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Address
87660
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Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
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Country
87660
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Australia
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Phone
87660
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+61 408435260
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Fax
87660
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Email
87660
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Per ethics approval.
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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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