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The SAFE Study: a landmark trial of the safety of albumin in intensive care

Simon R Finfer, Neil W Boyce and Robyn N Norton
Med J Aust 2004; 181 (5): . || doi: 10.5694/j.1326-5377.2004.tb06258.x
Published online: 6 September 2004

High-quality primary evidence from an Australian and New Zealand study provides a definitive answer


  • 1 Australian and New Zealand Intensive Care Society, Melbourne, VIC.
  • 2 Australian Red Cross Blood Service, Melbourne, VIC.
  • 3 The George Institute for International Health, University of Sydney, Sydney, NSW.


Correspondence: 

Competing interests:

All three authors played prominent roles in the design, conduct and publication of the SAFE Study.

  • 1. Cochrane Injuries Group Albumin Reviewers. Human albumin administration in critically ill patients: systematic review of randomised controlled trials. BMJ 1998; 317: 235-240.
  • 2. Wilkes MM, Navickis RJ. Patient survival after human albumin administration: a meta-analysis of randomized, controlled trials. Ann Intern Med 2001; 135: 149-164.
  • 3. Summaries for patients. Whether albumin therapy improves or worsens survival of critically ill patients is not known. Ann Intern Med 2001; 135: S-25.
  • 4. The SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med 2004; 350: 2247-2256.
  • 5. Cook D. Is albumin safe? [editorial] N Engl J Med 2004; 350: 2294-2296.
  • 6. ANZICS Clinical Trials Group and Institute for International Health SAFE Study Investigators. The Saline vs. Albumin Fluid Evaluation (SAFE) Study (ISRCTN76588266): design and conduct of a multi-centre, blinded randomised controlled trial of intravenous fluid resuscitation in critically ill patients. Available at: bmj.com/cgi/content/full/326/7389/559/DC1 (accessed Jun 2004).
  • 7. Choi PT, Yip G, Quinonez LG, Cook DJ. Crystalloids vs. colloids in fluid resuscitation: a systematic review. Crit Care Med 1999; 27: 200-210.
  • 8. Nicholson JP, Wolmarans MR, Park GR. The role of albumin in critical illness. Br J Anaesth 2000; 85: 599-610.
  • 9. Lewis CA, Martin GS. Understanding and managing fluid balance in patients with acute lung injury. Curr Opin Crit Care 2004; 10: 13-17.

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