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.
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.
The George Institute for Global Health
7,000 participants
Dec 1, 2009
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria33
- 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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Interventions
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).
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12609000245291