Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Simon Finfer
ORCID ID
Contact details
Intensive Care Unit
Royal North Shore Hospital
Pacific Highway
St. Leonard's
Sydney
2065
Australia
+61 (0)2 9926 8656
sfinfer@med.usyd.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00220987
Protocol/serial number
293201; SUGAR NCT00175331; NICE NCT00220987
Study information
Scientific title
A multi-centre, open label randomised stratified controlled trial of the effects of blood glucose management on 90-day all-cause mortality in a heterogeneous population of intensive care unit (ICU) patients
Acronym
NICE-SUGAR STUDY
Study hypothesis
The hypothesis is that there is no 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.
Acronym meaning: Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation
Ethics approval
Canadian main site: Clinical Research Ethics Board of the University of British Columbia, Vancouver approved on 21st March 2006
Study design
Randomised, parallel, two armed trial, with outcome assessor and data analyst blinding
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hyperglycaemia in critically ill patients
Intervention
The total projected recruitment for this trial is 6000 patients: 4000 in Australia and New Zealand (between April 2005 and December 2006) and 2000 in Canada (between May 2006 and September 2009). The Canadian leg of the trial will start on 01/05/2006 and is anticipated to run until the 30/09/2009.
Interventions for all participating centres:
Each participant will be randomised to receive an insulin sliding scale regimen to control blood glucose concentration between 4.5 - 6.0 mmol/l or insulin infused if blood glucose exceeds 10.0 mmol/l, and adjusted when needed to maintain blood glucose between 8.0 - 10.0 mmol/l
The trial sponsors for the Canadian leg of trial are:
1. The University of British Columbia
2329 West Mall
Vancouver
BC Canada
V6T 1Z4
2. Vancouver Coastal Health Research Institute
828 West 10th Avenue
Vancouver
BC, Canada
V5Z 1L8
3. George Institute for International Health
For further information on Canadian arm of trial, please contact the following:
1. Dr Vinay Dhingra at vinay.dhingra@vch.ca
2. Denise Foster, RN, CRC at Denise.Foster@vch.ca
Intervention type
Drug
Phase
Not Applicable
Drug names
Glucose, insulin
Primary outcome measure
90 day all-cause mortality
Secondary outcome measures
Determined over the same period (90 days):
1. Death in intensive care unit by day 28 and by 90 days
2. Length of intensive care unit stay
3. Length of hospital stay
4. The need for organ support (intropes, renal replacement therapy and positive pressure ventilation)
5. Incidence of blood stream infections
6. Incidence and severity of hypoglycaemia
Also in a subgroup of patients admitted with a diagnosis of traumatic brain injury, a follow up to determine long term functional status as determined by Extended Glasgow Outcome Scores (GOSE) will be collected at day 90 and six months.
Overall trial start date
04/04/2005
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients (18 years or over, either sex) that are expected to require treatment in the ICU that extends beyond the calendar day following the day of admission
2. Patient has an arterial line in place or placement of an arterial line is imminent (within the next hour) as part of routine ICU management
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
6000 (2207 patients recruited as of 4/08/06)
Participant exclusion criteria
Patients are excluded from the study if ONE or MORE of the following criteria are present:
1. Age less than 18 years
2. Imminent death and the treating clinicians are not committed to full supportive care
3. Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state
4. Patients that are expected to be eating before the end of the day following admission
5. Patients who have suffered hypoglycaemia without documented full neurological recovery
6. Patients thought to be at abnormally high risk of suffering hypoglycaemia
7. If a patient has previously been enrolled in the study
8. If the patient cannot 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
Recruitment start date
04/04/2005
Recruitment end date
30/09/2009
Locations
Countries of recruitment
Australia, Canada, New Zealand
Trial participating centre
Intensive Care Unit
Sydney
2065
Australia
Sponsor information
Organisation
Australian and New Zealand Intensive Care Society (Australia)
Sponsor details
Level 3
10 Levers Terrace
Carlton
Victoria
3053
Australia
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
Australian National Health and Medical Research Council (NHMRC) (Australia) (ref: 293201)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
New Zealand Health Research Council (New Zealand) (ref: 05/078)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - www.cihr-irsc.gc.ca (ref: MCT-80244)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19318384
Publication citations
-
Results
, Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ, Intensive versus conventional glucose control in critically ill patients., N. Engl. J. Med., 2009, 360, 13, 1283-1297, doi: 10.1056/NEJMoa0810625.