Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE - SUGAR STUDY)
NCT00220987 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6104
Last updated 2009-01-29
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 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.
Conditions
- Hyperglycemia
- Critical Illness
Interventions
- OTHER
-
Intensive Insulin Therapy
Maintain blood glucose 4.5 - 6.o mmol/L
- OTHER
-
Conventional Insulin therapy
Maintain blood glucose 8-10mmol/L
Sponsors & Collaborators
-
Australian and New Zealand Intensive Care Society Clinical Trials Group
collaborator NETWORK -
Canadian Critical Care Trials Group
collaborator OTHER -
National Health and Medical Research Council, Australia
collaborator OTHER -
Health Research Council, New Zealand
collaborator OTHER -
University of British Columbia
collaborator OTHER -
The George Institute
lead OTHER
Principal Investigators
-
Simon Finfer, MBBS · Royal North Shore Hospital
-
John Myburgh, MBBS · St. George Hospital, Sydney
-
Rinaldo Bellomo, MBBS · Austin Hospital, Melbourne Australia
-
Imogen Mitchell, MBBS · The Canberra Hospital, ACT
-
Colin McArthur, MBBS · Auckland Hospital, New Zealand
-
Robyn Norton, Prof. · The George Institute
-
Suzanne McEvoy, MBBS · The George Institute
-
Leonie J Crampton, RN; CNS · The George Institute
-
Julie Potter, RN · Royal North Shore Hospital
-
Vinay Dhingra, MBBS · Vancouver General Hospital
-
Deborah Cook, MBBS · St. Joseph's Hospital, Ontario
-
Paul Hebert, MBBS · The Ottawa Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2008-11-30
- Completion
- 2008-11-30
Countries
- Australia
Study Locations
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