The effects of blood glucose management on 90-day all-cause mortality intensive care unit (ICU) patients
| ISRCTN | ISRCTN04968275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04968275 |
| ClinicalTrials.gov number | NCT00220987 |
| Secondary identifying numbers | 293201; SUGAR NCT00175331; NICE NCT00220987 |
- Submission date
- 26/08/2004
- Registration date
- 25/10/2004
- Last edited
- 18/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Simon Finfer
Scientific
Scientific
Intensive Care Unit
Royal North Shore Hospital
Pacific Highway
St. Leonard's
Sydney
2065
Australia
| Phone | +61 (0)2 9926 8656 |
|---|---|
| sfinfer@med.usyd.edu.au |
Study information
| Study design | Randomised, parallel, two armed trial, with outcome assessor and data analyst blinding |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 acronym | NICE-SUGAR STUDY |
| Study objectives | 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(s) | Canadian main site: Clinical Research Ethics Board of the University of British Columbia, Vancouver approved on 21st March 2006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 04/04/2005 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 6000 (2207 patients recruited as of 4/08/06) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/04/2005 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- Australia
- Canada
- New Zealand
Study participating centre
Intensive Care Unit
Sydney
2065
Australia
2065
Australia
Sponsor information
Australian and New Zealand Intensive Care Society (Australia)
Research organisation
Research organisation
Level 3, 10 Levers Terrace
Carlton
Victoria
3053
Australia
| Website | http://www.anzics.com.au/ctg/about.htm |
|---|---|
"ROR" |
https://ror.org/007847151 |
Funders
Funder type
Research council
Australian National Health and Medical Research Council (NHMRC) (Australia) (ref: 293201)
No information available
New Zealand Health Research Council (New Zealand) (ref: 05/078)
No information available
Canadian Institutes of Health Research (CIHR) (Canada) - www.cihr-irsc.gc.ca (ref: MCT-80244)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/03/2009 | Yes | No |
