Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE - SUGAR STUDY)

Launched by THE GEORGE INSTITUTE · Sep 14, 2005

Keywords

ClinConnect Summary

The NICE-SUGAR study is a multi-centre, open label, randomised controlled trial of blood glucose management with an intensive insulin regimen to maintain blood glucose between 4.5 - 6.0 mmol/L versus an insulin regimen maintaining blood glucose less than 10.0 mmol/L with insulin being infused if blood glucose exceeds 10.0 mmol/L, and adjusted when needed to maintain blood glucose between 8.0 - 10.0 mmol/L.

To ensure patient safety, the target blood glucose concentration must be closely monitored and the results known to the clinical staff treating the patients. As patient safety is paramou...

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Eligibility criteria

• Inclusion Criteria:
• * Patients are eligible for INCLUSION in the study if ALL the following criteria are met:
• • 1. At time of the patient's admission to the ICU the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission.
• • 2. Patient has an arterial line in situ or placement of an arterial line is imminent (within the next hour) as part of routine ICU management.
• Exclusion Criteria:
• Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:
• • 1. Age \< 18 years.
• • 2. Imminent death (cardiac standstill or brain death anticipated in less than 24 hours) and the treating clinicians are not committed to full supportive care. This should be confirmed by a documented treatment-limitation order that exceeds a "not-for-resuscitation" order.
• • 3. Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state.
• • 4. Patient is expected to be eating before the end of the day following admission
• • 5. Patients who have suffered hypoglycaemia without documented full neurological recovery.
• • 6. Patient thought to be at abnormally high risk of suffering hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or fulminant hepatic failure)
• • 7. If a patient has previously been enrolled in the NICE-SUGAR Study (patients cannot be enrolled in the NICE-SUGAR Study more than once).
• • 8. If the patient can not provide prior informed consent, there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent
• • 9. The patient has been in the study ICU or another ICU for longer than 24 hours for this admission.
• • There is no upper age limit for inclusion into the study unless any of the specific exclusion criteria are present.
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