CompletedPhase 3Phase 4ACTRN12609000245291

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.


Sponsor

The George Institute for Global Health

Enrollment

7,000 participants

Start Date

Dec 1, 2009

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This large study compares two types of intravenous fluids — a starch-based solution and regular saline — for critically ill patients in intensive care who need fluid resuscitation to maintain their blood volume. It aims to find out which fluid is safer and more effective. Participants are ICU patients aged 18 and older whose doctors believe either fluid would be appropriate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).

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)

Auckland, Wellington, Christchurch, Waikato, Tauranga, New Zealand

New Zealand

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ACTRN12609000245291