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Trial registered on ANZCTR
Registration number
ACTRN12624001416583
Ethics application status
Approved
Date submitted
12/11/2024
Date registered
2/12/2024
Date last updated
25/01/2025
Date data sharing statement initially provided
2/12/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A registry-based before and after retrospective observational study of change in the renal management of cardiac surgical patients admitted to Australian Intensive Care Units
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Scientific title
A registry-based before and after retrospective observational study of change in the renal management of cardiac surgical patients admitted to Australian Intensive Care Units
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Secondary ID [1]
313362
0
Nil known
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Universal Trial Number (UTN)
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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:
Acute kidney injury
335837
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Cardiac surgery
335718
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Condition category
Condition code
Renal and Urogenital
332415
332415
0
0
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Kidney disease
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Surgery
332416
332416
0
0
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Surgical techniques
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Cardiovascular
332285
332285
0
0
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Other cardiovascular diseases
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Cardiovascular
332284
332284
0
0
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Coronary heart disease
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
1
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Target follow-up type
Years
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Description of intervention(s) / exposure
Using data obtained from the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS) registry we retrospectively collect participant demographics, surgical characteristics, hospital care interventions and complications for the 'after period' which associated amino acid therapy. Specifically, data will be collected annually for the future 3-year period: 1st January 2025 until 31st December 2027.
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Intervention code [1]
329944
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Not applicable
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Comparator / control treatment
Using data obtained from the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS) registry we retrospectively collect participant demographics, surgical characteristics, hospital care interventions and complications for the 'before period' which did not involve the administration of amino acid therapy for the 3 years: 1st January 2022 to 31st December 2024.
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Control group
Historical
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Outcomes
Primary outcome [1]
339857
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The occurrence of acute kidney injury within the first week after cardiac surgery, with acute kidney injury defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for stage 1 or greater acute kidney injury. Stage 1 acute kidney injury is defined as an increase in the serum creatinine level of at least 0.3 mg per decilitre (26.5 micromol per litre) during a 48-hour period or a 50% increase from baseline during a 1-week period, stage 2 as a doubling of the baseline serum creatinine level, and stage 3 as a tripling of the baseline serum creatinine level or the initiation of dialysis, with either occurring within 1 week after the insult (e.g., cardiac surgery).
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Assessment method [1]
339857
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Assessed by data linkage to registry records
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Timepoint [1]
339857
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Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
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Secondary outcome [1]
441659
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In-hospital use of continuous renal-placement therapy from the date of the cardiac surgery through to discharge from hospital.
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Assessment method [1]
441659
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Assessed by data linkage to registry records
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Timepoint [1]
441659
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Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
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Secondary outcome [2]
441665
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Duration of mechanical ventilation in hours from the date of the cardiac surgery through to discharge from hospital.
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Assessment method [2]
441665
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Assessed by data linkage to registry records
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Timepoint [2]
441665
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Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
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Secondary outcome [3]
441660
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In-hospital duration of continuous renal-placement therapy from the date of the cardiac surgery through to discharge from hospital.
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Assessment method [3]
441660
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Assessed by data linkage to registry records
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Timepoint [3]
441660
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Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
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Secondary outcome [4]
441666
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Death from any cause documented at the time of ICU discharge, hospital discharge, or 30, 90, or 180 days after the date of cardiac surgery.
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Assessment method [4]
441666
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Assessed by data linkage to registry records
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Timepoint [4]
441666
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Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
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Secondary outcome [5]
441661
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Duration of intensive care unit admission in hours from the time of arrival to the intensive care unit until discharge from the intensive care unit.
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Assessment method [5]
441661
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Assessed by data linkage to registry records
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Timepoint [5]
441661
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Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
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Secondary outcome [6]
441662
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Duration of hospital admission in days from the date of the cardiac surgery through to discharge from hospital.
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Assessment method [6]
441662
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Assessed by data linkage to registry records
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Timepoint [6]
441662
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Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
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Eligibility
Key inclusion criteria
We will include all adult patients who undergoing a cardiac surgical procedure requiring cardiopulmonary bypass and are admitted to an Intensive Care Unit in Australia
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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
none
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Both
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Statistical methods / analysis
Analysis following data-linkage will be led by bio-statistician proficient in the analysis of large data sets. Statistical analyses will be performed using R version 4.4.0 (R Foundation for Statistical Computing). Baseline characteristics will be reported as frequencies and percentages, means ? standard deviation, or medians and interquartile ranges. Summary statistics to compare baseline characteristics will include t-test, chi squared test, Fisher exact test, and Wilcoxon rank sum test, as dictated by data type. The primary outcome will be reported using multivariable mixed effects linear regression models. Secondary outcomes will be explored using multivariable linear regression models for continuous outcomes and logistic regression models for binary outcomes. No imputation will be performed for missing data. A two-sided p-value <0.05 will be considered significant.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/01/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2027
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Actual
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Date of last data collection
Anticipated
31/01/2028
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Actual
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Sample size
Target
30000
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
27319
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St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
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Recruitment hospital [2]
27315
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [3]
27320
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Victorian Heart Hospital - Clayton
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Recruitment hospital [4]
27318
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St Vincent's Private Hospital - Fitzroy
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Recruitment hospital [5]
27321
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The Alfred - Melbourne
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Recruitment hospital [6]
27322
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Warringal Private Hospital - Heidelberg
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Recruitment hospital [7]
27323
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
43410
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3002 - East Melbourne
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Recruitment postcode(s) [2]
43411
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3168 - Clayton
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Recruitment postcode(s) [3]
43406
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3084 - Heidelberg
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Recruitment postcode(s) [4]
43409
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3065 - Fitzroy
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Recruitment postcode(s) [5]
43412
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3004 - Melbourne
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Recruitment postcode(s) [6]
43413
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
317803
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Government body
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Name [1]
317803
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Austin Health
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Address [1]
317803
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Country [1]
317803
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Australia
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Primary sponsor type
Government body
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Name
Austin Health
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Address
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Country
Australia
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Secondary sponsor category [1]
320132
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None
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Name [1]
320132
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Address [1]
320132
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Country [1]
320132
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316486
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
316486
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
316486
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Australia
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Date submitted for ethics approval [1]
316486
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14/11/2024
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Approval date [1]
316486
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16/12/2024
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Ethics approval number [1]
316486
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Summary
Brief summary
Approximately 15,000 cardiac operations requiring cardiopulmonary bypass are undertaken in Australia each year. Major cardiac surgery necessitates the admission to the Intensive Care Unit for immediate and early post-operative care. Acute kidney injury (AKI) is a common and serious postoperative complication of cardiac surgery with an incidence rate of 5-42%. Cardiac surgery-associated AKI (CSA-AKI) has significant impacts on patients' morbidity, mortality, and healthcare costs. The PROTECTION trial which involved the administration of intravenous amino acids to patients undergoing cardiac surgery, and published in the New England Journal of Medicine (PMID 38865168) should improved renal outcomes for those who received the amino acid therapy compared to those who received the placebo. Crucially, with the publication of the PROTECTION trial, practice change locally, nationally, and international is occurring or likely to occur. In response, evaluating such practice change is a key component of recognising and responding to trends in care and outcomes that are otherwise invisible. We aim to perform a registry-based before and after observational study to evaluate change in the management of cardiac surgical patients admitted to Australian Intensive Care Units. Specifically, we wish to evaluate the change in key practice areas concerning renal injury identification and management. The total evaluable period of time for this before-and-after study is 6 years: 1st January 2022 until 20 – 31st December 2027. Data will be obtained from the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS) registry.
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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
138050
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Prof Rinaldo Bellomo
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Address
138050
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
138050
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Australia
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Phone
138050
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+61 394965992
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Fax
138050
0
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Email
138050
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[email protected]
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Contact person for public queries
Name
138051
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Rinaldo Bellomo
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Address
138051
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
138051
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Australia
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Phone
138051
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+61 394965992
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Fax
138051
0
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Email
138051
0
[email protected]
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Contact person for scientific queries
Name
138052
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Rinaldo Bellomo
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Address
138052
0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
138052
0
Australia
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Phone
138052
0
+61 394965992
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Fax
138052
0
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Email
138052
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
This is a translational of research into practice trial.
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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