Crystalloid Versus Hydroxyethyl Starch Trials

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.

Conditions

• Intensive Care

Interventions

DRUG

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

DRUG

Saline

Maximum dose of 50ml/kg/day of saline for intravascular volume fluid resuscitation

Sponsors & Collaborators

• University of Sydney

  collaborator OTHER

• Australian and New Zealand Intensive Care Society Clinical Trials Group

  collaborator NETWORK

• Fresenius Kabi

  collaborator INDUSTRY

• The George Institute

  lead OTHER

Principal Investigators

• John A Myburgh, PhD FJFICM · The George Institute

• Simon Finfer · Royal North Shore Hospital, NSW, Australia

• David Gattas · Royal Prince Alfred Hospital, NSW, Australia

• Eddie Stachowski · Westmead Hospital, NSW, Australia

• Michael Parr · Liverpool Hospital, NSW, Australia

• Ian Seppelt · Nepean Hospital, NSW, Australia

• Peter Harrigan · John Hunter Hospital, NSW, Australia

• Rinaldo Bellomo · Austin Hospital, VIC, Australia

• Forbes McGain · Western Hospital, VIC, Australia

• Rob Boots · Royal Brisbane & Women's Hospital, QLD, Australia

• Jason Fletcher · Bendigo Health, VIC, Australia

• David Milliss · Concord Hospital, NSW, Australia

• Benno Ihle · Epworth Richmond, VIC, Australia

• David Ernest · Box Hill Hospital, VIC, Australia

• Jeffrey Presneill · Mater Health Services, QLD, Australia

• Claire Cattigan · Geelong Hospital, VIC, Australia

• Katrina Ellem · Calvary Mater Newcastle, NSW, Australia

• Seton Henderson · Christchurch Hospital, New Zealand

• Shay McGuinness · Auckland CVICU, New Zealand

• Dick Dinsdale · Wellington Hospital, New Zealand

• Michael Reade · The Northen Hospital, VIC, Australia

• Bart de Keulenaer · Fremantle Hospital, WA, Australia

• Latesh Poojara · Blacktown Hospital, NSW, Australia

• Yahya Shehabi · Prince of Wales Hospital, NSW, Australia

• Imogen Mitchell · The Canberra Hospital, ACT, Australia

• John Santamaria · St Vincent's Hospital, VIC, Australia

• Troy Browne · Tauranga Hospital, New Zealand

• Kavi Haji · Frankston Hospital, VIC Australia

• Frank van Haren · Waikato Hospital, New Zealand

• Janet Liang · North Shore Hospital, New Zealand

• Bala Venkatesh · Wesley Hospital, VIC, Australia

• David Cooper · Royal Hobart Hospital, TAS, Australia

• John Myburgh · St George Hospital, NSW, Australia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2012-04-30

Completion

2012-09-30

Countries

• Australia

Study Locations