Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE - SUGAR STUDY)
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|ClinicalTrials.gov Identifier: NCT00220987|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 29, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Hyperglycemia Critical Illness||Other: Intensive Insulin Therapy Other: Conventional Insulin therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open Label Randomized Stratified Controlled Trial of the Effects of Blood Glucose Management on 90-Day All-Cause Mortality in a Heterogenous Population of Intensive Care Unit (ICU) Patients.|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: Intensive Insulin therapy
Intensive Insulin therapy
Other: Intensive Insulin Therapy
Maintain blood glucose 4.5 - 6.o mmol/L
Active Comparator: Conventional Therapy
conventional insulin therapy
Other: Conventional Insulin therapy
Maintain blood glucose 8-10mmol/L
- all-cause mortality [ Time Frame: 90 days ]
- The secondary outcomes, also determined over the same period of 90 days include: [ Time Frame: 90 days ]
- All cause mortality [ Time Frame: Day 28 ]
- Length of intensive care unit stay; [ Time Frame: 90 days ]
- Length of hospital stay; [ Time Frame: 90 Days ]
- The need for organ support (inotropes, renal replacement therapy and positive pressure ventilation); [ Time Frame: 90 Days ]
- Incidence of blood stream infections; [ Time Frame: 90 Days ]
- Incidence and severity of hypoglycaemia; [ Time Frame: 90 Days ]
- extended glasgow outcome score [ Time Frame: 2 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220987
|Australia, New South Wales|
|The George Institute for International Health|
|Camperdown, New South Wales, Australia, 2050|
|Study Chair:||Simon Finfer, MBBS||Royal North Shore Hospital|
|Principal Investigator:||John Myburgh, MBBS||St. George Hospital, Sydney|
|Principal Investigator:||Rinaldo Bellomo, MBBS||Austin Hospital, Melbourne Australia|
|Principal Investigator:||Imogen Mitchell, MBBS||The Canberra Hospital, ACT|
|Principal Investigator:||Colin McArthur, MBBS||Auckland Hospital, New Zealand|
|Principal Investigator:||Robyn Norton, Prof.||The George Institute|
|Principal Investigator:||Suzanne McEvoy, MBBS||The George Institute|
|Principal Investigator:||Leonie J Crampton, RN; CNS||The George Institute|
|Principal Investigator:||Julie Potter, RN||Royal North Shore Hospital|
|Principal Investigator:||Vinay Dhingra, MBBS||Vancouver General Hospital|
|Principal Investigator:||Deborah Cook, MBBS||St. Joseph's Hospital, Ontario|
|Principal Investigator:||Paul Hebert, MBBS||The Ottawa Hospital|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Simon Finfer, The George Institute|
|Other Study ID Numbers:||
NHMRC GRANT - 293201
|First Posted:||September 22, 2005 Key Record Dates|
|Last Update Posted:||January 29, 2009|
|Last Verified:||January 2009|
Hyperglycemia in the critically ill patient
Intensive Insulin Therapy
Conventional insulin therapy
Glucose Metabolism Disorders
Insulin, Globin Zinc
Physiological Effects of Drugs