New study set to change how critically ill patients are treated across the world
Brussels, 24 March 2009 --- Australian and New Zealand clinicians, uncertain if intensively lowering blood glucose was harmful or beneficial to critically ill patients have found that blood glucose lowering increases the risk of dying by 10%. Results of the largest trial of intensive blood glucose lowering in intensive care patients published today in The New England Journal of Medicine indicate that international clinical practice and guidelines need urgent review.
Internationally, intensive blood glucose lowering has been widely recommended and embraced to control hyperglycemia (high blood sugar) which is extremely common among acutely ill patients and linked with serious complications such as organ failure and death. Local researchers were concerned with this treatment strategy and decided to conduct a large, landmark trial to confirm the best treatment for critically ill patients. These new findings reveal that international practice to intensively lower blood glucose actually increases the risk of death among intensive care unit (ICU) patients.
"Intensively lowering blood glucose in critically ill patients is not beneficial and may be harmful. Based on our findings, we do not recommend pursuing a normal blood glucose level in critically ill patients. We found that intensively lowering blood glucose levels increased a patient’s risk of dying by 10%," said Chief Investigator, Professor Simon Finfer from The University of Sydney’s George Institute for International Health.
Researchers from The Australian and New Zealand Intensive Care Society Clinical Trials Group, The George Institute for International Health, The Canadian Critical Care Trials Group and Vancouver Coastal Health Research Institute set out to clarify the target range for blood glucose levels in critically ill patients. They followed 6104 ICU patients in Australia, New Zealand, Canada and the USA for up to 90 days to assess whether the treatment would improve patients chance of survival.
"Previous, smaller research studies have produced conflicting results and overall suggested that intensive blood glucose control didn’t affect death rates in critically ill adults. This new study gives us more powerful information, based on this larger study with stronger evidence, we can conclude that targeting very low levels of blood glucose is not safe," said Professor John Myburgh from The University of Sydney’s George Institute for International Health.
In Australia over 125,000 people are admitted to ICUs each year and around 7,500 patients die in Australian ICUs each year. In New Zealand, every year 17,500 people are admitted to ICUs with around 1,200 patients dying. The new evidence suggests that current guidelines must be reviewed.
"It’s essential that international guidelines reflect this new evidence. Many professional organisations recommend very tight glucose control for ICU patients - they will now need to take this new evidence into consideration and adjust recommendations accordingly," said New Zealand researcher Dr. Colin McArthur, Auckland City Hospital.
The study, NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation) randomly assigned patients to one of two target ranges for blood glucose; an intensive control target (81-108mg/dL; 4.5-6.0 mmol/L) or a conventional control target (180mg/dL; 10.0 mmol/L or less). Control of blood glucose was achieved by the use of an intravenous infusion of insulin.
A unique feature of the NICE-SUGAR study was standardized complex blood glucose management, which was accessed by multiple centres as a computerised algorithm.
For further information, please contact:
AUSTRALIA
Emma Orpilla - Public Relations,
The George Institute for International Health
Tel: +612 9993 4500/ Mobile: +61410 411 983
Fax: +612 9993 4501/ email: eorpilla@george.org.au
NEW ZEALAND
Jenny Williams
Mobile: +64-21-366-664 Email: jennywi@adhb.govt.nz
Notes
- The NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation) study is a multi-centre, international, open label, randomised controlled trial of blood glucose management comparing two blood glucose targets.
- The study is a collaboration of The ANZICS Clinical Trials Group, The George Institute for International Health, The Canadian Critical Care Trials Group and Vancouver Coastal Health Research Institute
- Funding for the NICE-SUGAR study was provided by Australia’s National Health and Medical Research Council (NHMRC), the New Zealand Health Research Council (HRC) and the Canadian Institute of Health Research
- To read the findings in full, visit The New England Journal of Medicine
- Previous related publications include: The NICE-SUGAR Study Investigators. The Normoglycaemia in Intensive Care Evaluation (NICE) and Survival Using Glucose Algorithm Regulation (SUGAR) Study: Development, design and conduct of an international, multi-center, open label, randomized controlled trial of two target ranges for glycemic control in intensive care unit patients. Am J Resp Crit Care Med online supplement 2005.