Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/08/2004
Date assigned
25/10/2004
Last edited
18/08/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.thegeorgeinstitute.org

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 measures

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

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

http://www.anzics.com.au/ctg/about.htm

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19318384

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