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The effects of blood glucose management on 90-day all-cause mortality intensive care unit (ICU) patients
ISRCTN ISRCTN04968275
DOI 10.1186/ISRCTN04968275
ClinicalTrials.gov identifier NCT00220987
EudraCT number
Public title The effects of blood glucose management on 90-day all-cause mortality intensive care unit (ICU) patients
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
Serial number at source 293201; SUGAR NCT00175331; NICE NCT00220987
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
Lay summary
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
Countries of recruitment Australia, Canada, New Zealand
Disease/condition/study domain Hyperglycaemia in critically ill patients
Participants - 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
Participants - 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
Anticipated start date 04/04/2005
Anticipated end date 30/09/2009
Status of trial Completed
Patient information material
Target number of participants 6000 (2207 patients recruited as of 4/08/06)
Interventions 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
Primary outcome measure(s) 90 day all-cause mortality
Secondary outcome measure(s) 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.
Sources of funding 1. Australian National Health and Medical Research Council (NHMRC) (Australia) (ref: 293201)
2. New Zealand Health Research Council (New Zealand) (ref: 05/078)
3. Canadian Institutes of Health Research (CIHR) (Canada) - www.cihr-irsc.gc.ca (ref: MCT-80244)
Trial website http://www.thegeorgeinstitute.org
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19318384
Contact name Prof  Simon  Finfer
  Address Intensive Care Unit
Royal North Shore Hospital
Pacific Highway
St. Leonard's
  City/town Sydney
  Zip/Postcode 2065
  Country Australia
  Tel +61 (0)2 9926 8656
  Fax +61 (0)2 9439 8418
  Email sfinfer@med.usyd.edu.au
Sponsor Australian and New Zealand Intensive Care Society (Australia)
  Address Level 3, 10 Levers Terrace
Carlton
  City/town Victoria
  Zip/Postcode 3053
  Country Australia
  Sponsor website: http://www.anzics.com.au/ctg/about.htm
Date applied 26/08/2004
Last edited 18/08/2010
Date ISRCTN assigned 25/10/2004
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