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The effects of blood glucose management on 90-day all-cause mortality intensive care unit (ICU) patients

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04968275
Enrollment
6000
Registered
2004-10-25
Start date
2005-04-04
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycaemia in critically ill patients Nutritional, Metabolic, Endocrine Hyperglycaemia

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

Sponsors

Australian and New Zealand Intensive Care Society (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
90 day all-cause mortality

Secondary

MeasureTime frame
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.

Countries

Australia, Canada, New Zealand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026