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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
8/02/2012
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.
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.
Secondary ID [1] 251988 0
NCT00935168
Universal Trial Number (UTN)
Trial acronym
CHEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fluid resuscitation in intensive care patients 4124 0
Condition category
Condition code
Other 4319 4319 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 3834 0
Treatment: Drugs
Comparator / control treatment
Intravenous fluid resuscitation with 0.9% sodium chloride for all fluid resuscitation episodes during the duration of stay in the ICU.
Control group
Active

Outcomes
Primary outcome [1] 5209 0
All cause mortality
Timepoint [1] 5209 0
90 days after randomisation
Secondary outcome [1] 8766 0
Renal failure requiring renal replacement therapy will be assessed using hospital records.
Timepoint [1] 8766 0
During intensive care Unit (ICU) stay after randomisation
Secondary outcome [2] 8767 0
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.
Timepoint [2] 8767 0
During ICU stay after randomisation
Secondary outcome [3] 8768 0
ICU, hospital and 28 day mortality
Timepoint [3] 8768 0
At 28 days and 6 months after randomisation
Secondary outcome [4] 8769 0
Quality of life will be assessed using the EQ-5D questionnaire.
Timepoint [4] 8769 0
6 months after randomisation
Secondary outcome [5] 9112 0
Functional status will be assessed using the Glasgow Outcome score.
Timepoint [5] 9112 0
6 months after randomisation.

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1472 0
New Zealand
State/province [1] 1472 0
Auckland, Wellington, Christchurch, Waikato, Tauranga
Country [2] 1473 0
New Zealand
State/province [2] 1473 0

Funding & Sponsors
Funding source category [1] 4459 0
University
Name [1] 4459 0
The University of Sydney
Address [1] 4459 0
The University of Sydney, New South Wales, 2006
Country [1] 4459 0
Australia
Funding source category [2] 5017 0
Commercial sector/Industry
Name [2] 5017 0
Fresenius Kabi (partial funder, unrestricted)
Address [2] 5017 0
Fresenius Kabi Deutschland GmbH Kabi Innovation Centre Else-Kroner-Strasse 1 61352 Bad Homburg
Country [2] 5017 0
Germany
Funding source category [3] 257120 0
Government body
Name [3] 257120 0
NHMRC Project Grant
Address [3] 257120 0
Canberra
Country [3] 257120 0
Australia
Funding source category [4] 257121 0
Government body
Name [4] 257121 0
NSW Department of Health
Address [4] 257121 0
Sydney
Country [4] 257121 0
Australia
Primary sponsor type
Other
Name
The George Institute for International Health
Address
Level 7, 341 George Street SYDNEY New South Wales 2000
Country
Australia
Secondary sponsor category [1] 4046 0
None
Name [1] 4046 0
Address [1] 4046 0
Country [1] 4046 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6337 0
Northen Sydney Central Coast Human Research Ethics Committee (HREC)
Ethics committee address [1] 6337 0
Level 4, Vindin House Royal North Shore Hospital ST LEONARDS NSW 2065
Ethics committee country [1] 6337 0
Australia
Date submitted for ethics approval [1] 6337 0
06/01/2009
Approval date [1] 6337 0
Ethics approval number [1] 6337 0
HREC/09/HARBR/14/15

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35037 0
Address 35037 0
Country 35037 0
Phone 35037 0
Fax 35037 0
Email 35037 0
Contact person for public queries
Name 12384 0
Prof John Myburgh
Address 12384 0
The George Institute for International Health
Level 7 George Street SYDNEY New South Wales 2000
Country 12384 0
Australia
Phone 12384 0
+61 2 9657 0348
Fax 12384 0
+61 2 9657 0301
Email 12384 0
jmyburgh@george.org.au
Contact person for scientific queries
Name 3312 0
Prof John Myburgh
Address 3312 0
The George Institute for International Health
Level 7 George Street SYDNEY New South Wales 2000
Country 3312 0
Australia
Phone 3312 0
+61 2 9657 0348
Fax 3312 0
+61 2 9657 0301
Email 3312 0
jmyburgh@george.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary