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Sponsors and Collaborators: |
The George Institute Australian and New Zealand Intensive Care Society Clinical Trials Group Canadian Critical Care Trials Group National Health and Medical Research Council, Australia New Zealand Health Research Council University of British Columbia |
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Information provided by: | The George Institute |
ClinicalTrials.gov Identifier: | NCT00220987 |
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 at least one full calendar day. The hypothesis is that there is little difference in the relative risk of death between patients assigned a glucose range of 4.5 - 6.0 mmol/L, and those assigned a glucose range of 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 of 8.0 - 10.0 mmol/L.
Condition | Intervention | Phase |
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Hyperglycemia Critical Illness |
Other: Intensive Insulin Therapy Other: Conventional Insulin therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Enrollment: | 6104 |
Study Start Date: | April 2005 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intensive Insulin therapy: Experimental
Intensive Insulin therapy
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Other: Intensive Insulin Therapy
Maintain blood glucose 4.5 - 6.o mmol/L
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Conventional Therapy: Active Comparator
conventional insulin therapy
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Other: Conventional Insulin therapy
Maintain blood glucose 8-10mmol/L
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are eligible for INCLUSION in the study if ALL the following criteria are met:
Exclusion Criteria:
Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:
There is no upper age limit for inclusion into the study unless any of the specific exclusion criteria are present.
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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 | Ottawa General Hospital |
Responsible Party: | The George Institute ( Simon Finfer ) |
Study ID Numbers: | GI-IAT-NIC-G, NHMRC GRANT - 293201 |
Study First Received: | September 13, 2005 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00220987 History of Changes |
Health Authority: | Australia: National Health and Medical Research Council; New Zealand: Health Research Council; Canada: Canadian Institutes for Health Research |
Hyperglycemia in the critically ill patient Intensive Insulin Therapy Conventional insulin therapy Hypoglycaemia |
Hypoglycemic Agents Metabolic Diseases Hyperglycemia Critical Illness Benzocaine |
Glucose Metabolism Disorders Hypoglycemia Metabolic Disorder Insulin |
Disease Attributes Hypoglycemic Agents Metabolic Diseases Pathologic Processes Hyperglycemia |
Critical Illness Physiological Effects of Drugs Glucose Metabolism Disorders Pharmacologic Actions Insulin |