Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Simon Finfer


Contact details

Intensive Care Unit
Royal North Shore Hospital
Pacific Highway
St. Leonard's
+61 (0)2 9926 8656

Additional identifiers

EudraCT number number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Hyperglycaemia in critically ill patients


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
BC Canada
V6T 1Z4
2. Vancouver Coastal Health Research Institute
828 West 10th Avenue
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
2. Denise Foster, RN, CRC at

Intervention type



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

Australia, Canada, New Zealand

Trial participating centre

Intensive Care Unit

Sponsor information


Australian and New Zealand Intensive Care Society (Australia)

Sponsor details

Level 3
10 Levers Terrace

Sponsor type

Research organisation



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


Funder name

New Zealand Health Research Council (New Zealand) (ref: 05/078)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - (ref: MCT-80244)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

  1. 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.

Additional files

Editorial Notes