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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00935168
Registration number
NCT00935168
Ethics application status
Date submitted
1/07/2009
Date registered
8/07/2009
Date last updated
16/11/2012
Titles & IDs
Public title
Crystalloid Versus Hydroxyethyl Starch Trials
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Scientific title
A Multi-centre Randomized Controlled Trial of Fluid Resuscitation With Starch (6%Hydroxyethyl Starch 130/0.4) Compared to Saline (0.9% Sodium Chloride) in Intensive Care Patients on Mortality
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Secondary ID [1]
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ACTRN12609000245291
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Secondary ID [2]
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GI-CCT24378
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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:
Intensive Care
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 6% Hydroxy-ethyl starch (130/0.4)
Treatment: Drugs - Saline
Experimental: Hydroxy-ethyl starch - Intravenous fluid resuscitation with 6% Hydroxy-ethyl starch (130/0.4)
Active Comparator: Saline - Intravenous fluid resuscitation with saline (0.9% sodium chloride)
Treatment: Drugs: 6% Hydroxy-ethyl starch (130/0.4)
Maximum dose of 50ml/kg/day of 6% hydroxy-ethyl starch (130/0.4) for intravascular volume fluid resuscitation
Treatment: Drugs: Saline
Maximum dose of 50ml/kg/day of saline for intravascular volume fluid resuscitation
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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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
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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 up to 90 days
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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 biochemical and bio-physiological parameters recorded 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 up to 90 days
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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
- Written informed consent has been obtained or if not possible, the procedure for
obtaining informed consent has been approved by the ethics committee.
- Fluid resuscitation is required to increase or maintain intravascular volume that is
in addition to maintenance fluids, enteral and parenteral nutrition, blood products
and specific replacement fluids to replace ongoing insensible or fluid losses from
other sites (e.g., fistula losses from the gastrointestinal tract, urinary losses from
diabetes insipidus or the polyuric phase of acute renal failure or to correct
metabolic derangements).
- The ICU clinician considers that both 6% hydroxyethyl starch (130/0.4) and saline are
equally appropriate for the patient and that no specific indication or
contraindication for either exists.
- The requirement for fluid resuscitation must be supported by AT LEAST ONE of the
following clinical signs:
1. Heart rate > 90 beats per minute
2. Systolic blood pressure (SBP) < 100mmHg or mean arterial pressure (MAP) < 75mmHg
or at least 40mmHg decrease in SBP or MAP from the baseline recording
3. Central venous pressure < 10mmHg
4. Pulmonary artery wedge pressure < 12 mmHg
5. Respiratory variation in systolic or mean arterial blood pressure of >5 mmHg
6. Capillary refill time > one second
7. Urine output < 0.5 ml/kg for one hour
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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 hydroxyethyl starch solution.
- Primary non-traumatic intracranial haemorrhage or severe traumatic intracranial
haemorrhage (mass lesion > 25 ml).
- 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)
- Patients with documented serum creatinine value = 350µmol/L and urine output averaging
= 10ml / hr over 12 hours
- Severe hypernatraemia (Serum sodium > 160 mmol/l) or severe hyperchloraemia (Serum
chloride > 130 mmol/l).
- Women of child bearing age (18-49 years old), unless evidence of documented menopause,
hysterectomy or surgical sterilisation or negative pregnancy test before randomisation
- Breastfeeding
- Patients who have received > 1000mL hydroxyethyl starch in the 24 hours before
randomization.
- Patients admitted to the ICU following cardiac surgery; patients admitted to 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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2012
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Sample size
Target
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Accrual to date
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Final
7000
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The George Institute for International Health - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Australian and New Zealand Intensive Care Society Clinical Trials Group
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/Industry
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Name [3]
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Fresenius Kabi
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to determine whether patients in the Intensive Care Unit who receive
fluid resuscitation with either hydroxyethyl starch (a synthetic colloid solution) or saline
(a salt solution), have an increased rate of survival at 90 days.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00935168
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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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John A Myburgh, PhD FJFICM
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Address
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The George Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00935168
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