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Trial registered on ANZCTR
Registration number
ACTRN12609000245291
Ethics application status
Approved
Date submitted
11/12/2008
Date registered
12/05/2009
Date last updated
23/08/2024
Date data sharing statement initially provided
23/08/2024
Date results provided
23/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Crystalloid versus Hydroxy-Ethyl Starch Trial - A multi-centre randomized controlled trial of fluid resuscitation with starch (6% hydroxyl starch 130/0/4) compared to saline (0.9%) sodium chloride in intensive care patients on mortality.
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Scientific title
A multicentre randomised controlled trial of fluid resuscitation with 6% hydroxyethyl starch (130/0.4) compared to saline (0.9% sodium chloride) on all cause mortality in intensive care patients.
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Secondary ID [1]
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NCT00935168
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Universal Trial Number (UTN)
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Trial acronym
CHEST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fluid resuscitation in intensive care patients
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Condition category
Condition code
Other
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intravenous fluid resuscitation with 6% hydroxyethyl starch (130/0.4) for all fluid resuscitation episodes during the duration of stay in the intensive care unit (ICU).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
Intravenous fluid resuscitation with 0.9% sodium chloride for all fluid resuscitation episodes during the duration of stay in the ICU.
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Control group
Active
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Outcomes
Primary outcome [1]
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All cause mortality
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Assessment method [1]
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Timepoint [1]
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90 days after randomisation
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Secondary outcome [1]
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Renal failure requiring renal replacement therapy will be assessed using hospital records.
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Assessment method [1]
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Timepoint [1]
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During intensive care Unit (ICU) stay after randomisation
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Secondary outcome [2]
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Other organ failures will be assessed using the Sequential Organ Failure Assessment (SOFA) score which is based on bichemical and bipphysiological parameters recored in the hospital record.
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Assessment method [2]
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Timepoint [2]
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During ICU stay after randomisation
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Secondary outcome [3]
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ICU, hospital and 28 day mortality
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Assessment method [3]
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Timepoint [3]
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At 28 days and 6 months after randomisation
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Secondary outcome [4]
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Quality of life will be assessed using the EQ-5D questionnaire.
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Assessment method [4]
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Timepoint [4]
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6 months after randomisation
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Secondary outcome [5]
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Functional status will be assessed using the Glasgow Outcome score.
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Assessment method [5]
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Timepoint [5]
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6 months after randomisation.
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Eligibility
Key inclusion criteria
Fluid resuscitation required to maintain intravascular volume that is in addition to maintence, enteral/parenteral nutrition, blood products and specific replacement fluids to replace on-going or insensible fluid losses from other sites;
ICU physician considers both study fluids are equally appropriate;
Requirement for fluid resuscitation must be supported by at least one of 7 clinical signs.
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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
- Previous allergic reaction to hyrdroxyethyl starch solution;
- Primary non-traumatic intracranial haemorrhage or severe
traumatic intracranial haemorrhage (mass lesion>25ml);
- Patients who are receiving renal replacement therapy or
in whom the ICU physician considers renal replacement
therapy is imminent (i.e. renal replacement therapy will
start in 6 hours);
- Documented serum creatinine value >350umol/L AND
urine output averaging <10ml/hour over 12 hours;
- Severe hypernatraemia (Serum sodium > 160 mmol/l);
Severe hyperchloraemia (Serum chloride > 130 mmol/l);
- Women of child bearing age (18-49), unless evidence of
documented menopause, hysterectomy, or surgical
sterilisation. Unless -ve pregnancy test documented. OR if
patient is breastfeeding;
- Patients who have received > 1000mL hydroxyethyl starch
in the 24 hours before randomisation;
- Patients admitted to the ICU following cardiac surgery;
- Patients admitted to the ICU for the treatment of burns or
following liver transplantation surgery;
- Death is deemed imminent and inevitable or the patient
has an underlying disease process with a life expectancy
of <90 days;
- A limitation of therapy order has been documented
restricting implementation of the study protocol or the
treating clinician deems aggressive care unsuitable;
- Patient has previously been enrolled in the CHEST study;
- Patient has previously received fluid resuscitation that
was prescribed within the study ICU during this current
ICU admission;
- Patient has been transferred to the study ICU from
another ICU and received fluid resuscitation for the
treatment of volume depletion in that other ICU.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified by the intensive care physician. Allocation will be concealed and treatments assigned by a central web-based randomisation program.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified according to the participating institution and whether there is an admission diagnosis of trauma. Randomisation will be conducted using a minimisation algorithm.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
16/12/2009
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
1/01/2012
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
7000
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Accrual to date
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Final
7000
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland, Wellington, Christchurch, Waikato, Tauranga
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Country [2]
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New Zealand
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State/province [2]
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Sydney
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Address [1]
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The University of Sydney, New South Wales, 2006
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Fresenius Kabi (partial funder, unrestricted)
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Address [2]
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Fresenius Kabi Deutschland GmbH Kabi Innovation Centre Else-Kroner-Strasse 1 61352 Bad Homburg
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Country [2]
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Germany
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Funding source category [3]
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Government body
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Name [3]
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NHMRC Project Grant
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Address [3]
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Canberra
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Country [3]
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Australia
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Funding source category [4]
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Government body
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Name [4]
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NSW Department of Health
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Address [4]
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Sydney
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Country [4]
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Australia
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Primary sponsor type
Other
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Name
The George Institute for Global Health
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Address
Level 7, 341 George Street SYDNEY New South Wales 2000
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northen Sydney Central Coast Human Research Ethics Committee (HREC)
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Ethics committee address [1]
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Level 4, Vindin House Royal North Shore Hospital ST LEONARDS NSW 2065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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06/01/2008
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Approval date [1]
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06/01/2008
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Ethics approval number [1]
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HREC/09/HARBR/14/15
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Summary
Brief summary
Fluid resuscitation is widely used in the management of critically ill patients. There are a variety of different fluids available to doctors but there is little evidence regarding how effective they are which means that doctors often have little information on which to base their decisions regarding what fluid to choose. One of the most commonly used fluids in the world, a hydroxyethyl starch was recently approved by the Therapeutic Goods Administration for use in Australia. This project aims to compare how effective and safe this fluid is compared to another widely used fluid, saline, for resuscitation of critically ill patients admitted to intensive care units.
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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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Prof John Myburgh
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Address
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The George Institute for Global Health
Level 18, International Towers 3
300 Barangaroo Ave
Sydney NSW 2000
Australia
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Country
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Australia
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Phone
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+61280524381
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof John Myburgh
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Address
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The George Institute for Global Health
Level 18, International Towers 3
300 Barangaroo Ave
Sydney NSW 2000
Australia
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Country
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Australia
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Phone
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+61 2 9657 0348
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Fax
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+61 2 9657 0301
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof John Myburgh
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Address
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The George Institute for International Health
Level 7 George Street SYDNEY New South Wales 2000
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Country
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Australia
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Phone
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+61 2 9657 0348
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Fax
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+61 2 9657 0301
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Email
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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)?
Yes
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What data in particular will be shared?
Data sharing as per The George Institute's data sharing policy
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When will data be available (start and end dates)?
Data sharing as per The George Institute's data sharing policy
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Available to whom?
Data sharing as per The George Institute's data sharing policy
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Available for what types of analyses?
Data sharing as per The George Institute's data sharing policy
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How or where can data be obtained?
Data sharing as per The George Institute's data sharing policy
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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
Source
Title
Year of Publication
DOI
Embase
Hydroxyethyl starch versus saline for resuscitation of patients in intensive care: long-term outcomes and cost-effectiveness analysis of a cohort from CHEST.
2016
https://dx.doi.org/10.1016/S2213-2600%2816%2930120-5
N.B. These documents automatically identified may not have been verified by the study sponsor.
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