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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE - SUGAR STUDY)
Scientific title
A Multi-Center, Open Label Randomized Stratified Controlled Trial of the Effects of Blood Glucose Management on 90-Day All-Cause Mortality in a Heterogenous Population of Intensive Care Unit (ICU) Patients.
Secondary ID [1] 0 0
NHMRC GRANT - 293201
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycemia 0 0
Critical Illness 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Study type
Description of intervention(s) / exposure
Other interventions - Intensive Insulin Therapy
Other interventions - Conventional Insulin therapy

Experimental: Intensive Insulin therapy - Intensive Insulin therapy

Active Comparator: Conventional Therapy - conventional insulin therapy

Other interventions: Intensive Insulin Therapy
Maintain blood glucose 4.5 - 6.o mmol/L

Other interventions: Conventional Insulin therapy
Maintain blood glucose 8-10mmol/L

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
all-cause mortality
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
The secondary outcomes, also determined over the same period of 90 days include:
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
All cause mortality
Timepoint [2] 0 0
Day 28
Secondary outcome [3] 0 0
Length of intensive care unit stay;
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Length of hospital stay;
Timepoint [4] 0 0
90 Days
Secondary outcome [5] 0 0
The need for organ support (inotropes, renal replacement therapy and positive pressure ventilation);
Timepoint [5] 0 0
90 Days
Secondary outcome [6] 0 0
Incidence of blood stream infections;
Timepoint [6] 0 0
90 Days
Secondary outcome [7] 0 0
Incidence and severity of hypoglycaemia;
Timepoint [7] 0 0
90 Days
Secondary outcome [8] 0 0
extended glasgow outcome score
Timepoint [8] 0 0
2 years

Key inclusion criteria
- Patients are eligible for INCLUSION in the study if ALL the following criteria are

1. At time of the patient's admission to the ICU the treating ICU specialist expects
the patient will require treatment in the ICU that extends beyond the calendar
day following the day of admission.

2. Patient has an arterial line in situ or placement of an arterial line is imminent
(within the next hour) as part of routine ICU management.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are

1. Age < 18 years.

2. Imminent death (cardiac standstill or brain death anticipated in less than 24 hours)
and the treating clinicians are not committed to full supportive care. This should be
confirmed by a documented treatment-limitation order that exceeds a
"not-for-resuscitation" order.

3. Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar

4. Patient is expected to be eating before the end of the day following admission

5. Patients who have suffered hypoglycaemia without documented full neurological

6. Patient thought to be at abnormally high risk of suffering hypoglycaemia ( e.g. known
insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or
fulminant hepatic failure)

7. If a patient has previously been enrolled in the NICE-SUGAR Study (patients cannot be
enrolled in the NICE-SUGAR Study more than once).

8. If the patient can not 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

There is no upper age limit for inclusion into the study unless any of the specific
exclusion criteria are present.


Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The George Institute for International Health - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
The George Institute
Other collaborator category [1] 0 0
Name [1] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Name [2] 0 0
Canadian Critical Care Trials Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Name [4] 0 0
Health Research Council, New Zealand
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Name [5] 0 0
University of British Columbia
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Brief summary
The primary aim of the study is to compare the effects of the two blood glucose targets on 90
day all-cause mortality in Intensive Care patients who are predicted on admission to stay in
the ICU for at least one full calendar day. The hypothesis is that there is little 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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Simon Finfer, MBBS
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications