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Trans-Tasman investment in ICU trials a huge success

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In 1994, a small group of intensive care specialists set up the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). Their mission: to improve clinical research and the quality of evidence in intensive care medicine. With the support of the HRC and its Australian equivalent, the National Health and Medical Research Council (NHMRC), the group is estimated to have saved the New Zealand health care system well over $150 million per year over the past 10 years, and the lives of hundreds of New Zealanders.

More than 20,000 New Zealanders are treated in an intensive care unit (ICU) each year. Most are admitted because they have a potentially reversible life-threatening condition. The majority of ANZICS CTG research compares the relative effectiveness of standard treatments for these patients.

One of the areas where ANZICS CTG has made a substantial contribution to worldwide clinical practice is fluid therapy. The group’s first study to be published in the prestigious New England Journal of Medicine – the HRC/NHMRC-funded SAFE study – evaluated the risk of death in 7000 ICU patients receiving cheap saline intravenous fluid ($1.60/litre) compared with expensive albumin fluid ($332/litre).

The SAFE study in New Zealand was led by Dr Colin McArthur from the Auckland District Health Board, who has been involved in the trial group since soon after its inception and is currently lead researcher on three HRC-funded clinical trials. He says the SAFE study’s findings have influenced ICU practice around the world.

“The SAFE study showed that the expensive albumin fluid was not better than the much cheaper saline fluid, and it was actually harmful in patients with traumatic brain injury, increasing their risk of disability and death. If you’re a young patient with severe traumatic brain injury and you’re disabled, requiring lifelong hospital care, the cost to society is enormous.”

An independent economic agency in Australia, Access Economics, has estimated the cost savings from the SAFE study to be in the vicinity of $687 million per year. Dr McArthur says savings for New Zealand may well be proportionally similar – that is more than $137 million per year.

ANZICS CTG’s New Zealand representative, Dr Paul Young, an intensive care specialist from Capital and Coast District Health Board, has worked closely with Dr McArthur since first getting involved in research six years ago. In October last year, he published findings in the Journal of the American Medical Association comparing saline with a newer alternative fluid with lower chloride concentrations (Plasma Lyte®).

The HRC-funded trial – the largest ever carried out exclusively in New Zealand ICUs – was in response to recent data suggesting that saline solutions, which have been used in clinical medicine since the cholera epidemics of the 1830s, may increase the risk of patients developing kidney failure.

The study found that using saline did not increase the risk of developing kidney failure compared with using Plasma Lyte®. Dr Young says the results are of major significance for global public health because they provide reassurance about the safety of intravenous saline, which is currently administered to more than a million patients around the world every day.

“As more than a million litres of fluid are given to patients around the world every day – and saline is cheaper than the newer fluids by between 50 cents and $8, depending on the country – this study has the potential to lead to health care savings of millions of dollars every day on a global scale.”

The global impact of ANZICS CTG’s research extends into other areas of ICU practice as well. In 2005 the HRC, NHMRC, and Canadian Institutes of Health Research jointly funded the ‘NICE-SUGAR trial’ of 6000 critically ill patients who were being treated in an ICU to evaluate the effect of “tight” control of blood sugar – the global standard of care at the time for treating blood sugar levels, which are commonly elevated in critical illness.

Contrary to expectations, the group found that tight blood sugar control of ICU patients – where insulin is used to keep blood sugar in the normal range – actually increased mortality.

“So this highly labour-intensive therapy that was being commonly used all around the world – except in Australia and New Zealand – was actually killing people,” says Dr Young.

HRC Chief Executive Professor Kath McPherson says this is yet another example of the far-reaching benefits of investing in high quality clinical research.

“As a direct result of this study, tight blood sugar control is not routinely practiced in New Zealand. Every year this research is estimated to prevent three deaths for every 100 patients treated in ICUs. It’s completely changed clinical practice around the world,” says Professor McPherson.

The New England Medical Journal paper reporting the NICE-SUGAR trial findings has been cited some 3,347 times at last count. This makes it one of the most highly cited papers in the field of intensive care medicine ever.

Dr Young says it is only because the HRC has funded some of ANZICS CTG’s projects that the group exists. He says the HRC’s support has been crucial for attracting funding from other international trial networks into New Zealand.

“Over the past 10 years the HRC has invested about $7 million in intensive care research. That investment has paid for itself many, many times over with the direct cost savings for the New Zealand healthcare system from our clinical trials estimated to be well over $150 million per year. Hundreds of people admitted to New Zealand’s ICUs every year now survive as a result of the practice changes that have occurred in response to our trials’ findings.”

* The Australian and New Zealand Intensive Care Society Clinical Trials Group is a network of 80 hospitals in Australia and New Zealand involving more than 500 researchers, clinicians, research coordinators, and project officers. All major New Zealand intensive care units are members of the network.