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World’s largest study in Intensive Care

27 May 2004

World’s largest study in Intensive Care

New Zealand and Australian research results provide answers for Doctors across the world

After nearly six years of work, a group of New Zealand and Australian researchers have the answer to a question that has been concerning the medical profession for years: When faced with a critically ill patient, which is the safest way to keep their fluids up, and give them the best chance of survival?

Results, published in the current edition of the New England Journal of Medicine, show that the SAFE study (Saline versus Albumin Fluid Evaluation) has concluded there is no discernable difference in the death rate in intensive care patients resuscitated with two commonly used fluids – human albumin or saline.

The 7000 patient trial, an Australia-New Zealand collaboration, was prompted by a 1998 study (The Cochrane Review) – conducted by UK researchers and published in the BMJ (previously the British Medical Journal). The Review suggested albumin – a protein extracted from donated plasma – caused an increase in mortality among critically ill patients. Although the Cochrane Review changed medical practice (particularly in the UK) the report was widely criticised, and a common reaction amongst the medical community was that a large-scale randomised trial was needed to truly determine the safety of human albumin use.

With over 100,000 patients treated in New Zealand and Australian ICUs every year, and albumin widely used , SAFE researchers thought that the conclusions drawn in the Cochrane Review raised an important public health issue for millions of critically ill patients worldwide. With this in mind, a collaborative group of researchers from the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG), together with The George Institute for International Health (University of Sydney) and with assistance from the Australian Red Cross Blood Service and the New Zealand Blood Service, began SAFE, a study three times bigger than any previous Intensive Care Trial.

Dr Simon Finfer, Chair of the ANZICS CTG says the primary question of the SAFE study was clear: “Albumin is widely used in ICUs across the world and there was a question mark over its safety. We felt it was vital to determine whether or not it increased mortality in critically ill patients as other researchers had suggested.

As the biggest trial ever attempted in ICUs the SAFE Study was a very ambitious project, but the results are clear – for Intensive Care patients there is no increase in mortality when we compare albumin with saline, and either can be used safely,” he said.

Auckland and Middlemore Hospitals were the two New Zealand facilities among the 16 Intensive Care Units in Australia and New Zealand that took part in the study.

Dr Colin McArthur, Clinical Director of Auckland City Hospital’s Department of Critical Care Medicine, said clinicians now had clear, evidence-based information on which to make decisions about their choice of treatment.

Dr McArthur said the results of the study would have an impact well beyond Intensive Care Units. In New Zealand, emergency care specialties dealing with resuscitation had already begun to use more saline as the most cost-efficient of equally effective treatment options.

A secondary impact would be the strengthening of the research culture in Intensive Care.

ENDS

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