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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
ACTRN12609000245291
Secondary ID [2] 0 0
GI-CCT24378
Universal Trial Number (UTN)
Trial acronym
CHEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
7000
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for International Health - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Fresenius Kabi
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John A Myburgh, PhD FJFICM
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00935168