Status:
COMPLETED
Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE - SUGAR STUDY)
Lead Sponsor:
The George Institute
Collaborating Sponsors:
Australian and New Zealand Intensive Care Society Clinical Trials Group
Canadian Critical Care Trials Group
Conditions:
Hyperglycemia
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary aim of the study is to compare the effects of the two blood glucose targets on 90 day all-cause mortality in Intensive Care patients who are predicted on admission to stay in the ICU for a...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Patients are eligible for INCLUSION in the study if ALL the following criteria are met:
- 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.
- 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
- Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:
- Age \< 18 years.
- 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.
- Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state.
- Patient is expected to be eating before the end of the day following admission
- Patients who have suffered hypoglycaemia without documented full neurological recovery.
- 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)
- If a patient has previously been enrolled in the NICE-SUGAR Study (patients cannot be enrolled in the NICE-SUGAR Study more than once).
- 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
- 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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Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
6104 Patients enrolled
Trial Details
Trial ID
NCT00220987
Start Date
April 1 2005
End Date
November 1 2008
Last Update
January 29 2009
Active Locations (1)
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1
The George Institute for International Health
Camperdown, New South Wales, Australia, 2050