Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE - SUGAR STUDY)

NCT00220987 | Completed Phase 4 DMC

• 2 other identifiers: GI-IAT-NIC-GNHMRC GRANT - 293201
• Study Type: interventional
• Target: 6,104
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Critical Illness

Keywords

Hyperglycemia in the critically ill patient; Intensive Insulin Therapy; Conventional insulin therapy; Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  90 days

Secondary Outcomes (8)

• The secondary outcomes, also determined over the same period of 90 days include:

  90 days

• All cause mortality

  Day 28

• Length of intensive care unit stay;

  90 days

• Length of hospital stay;

  90 Days

• The need for organ support (inotropes, renal replacement therapy and positive pressure ventilation);

  90 Days

Study Arms (2)

Intensive Insulin therapy

EXPERIMENTAL

Intensive Insulin therapy

Other: Intensive Insulin Therapy

Conventional Therapy

ACTIVE COMPARATOR

conventional insulin therapy

Other: Conventional Insulin therapy

Interventions

Intensive Insulin Therapy OTHER

Maintain blood glucose 4.5 - 6.o mmol/L

Intensive Insulin therapy

Conventional Insulin therapy OTHER

Maintain blood glucose 8-10mmol/L

Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:
• Age \< 18 years.
• 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.
• Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state.
• Patient is expected to be eating before the end of the day following admission
• Patients who have suffered hypoglycaemia without documented full neurological recovery.
• 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)
• If a patient has previously been enrolled in the NICE-SUGAR Study (patients cannot be enrolled in the NICE-SUGAR Study more than once).
• 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
• The patient has been in the study ICU or another ICU for longer than 24 hours for this admission.

Sponsors & Collaborators

• The George Institute: lead
• Australian and New Zealand Intensive Care Society Clinical Trials Group: collaborator
• Canadian Critical Care Trials Group: collaborator
• National Health and Medical Research Council, Australia: collaborator
• Health Research Council, New Zealand: collaborator
• University of British Columbia: collaborator

Study Sites (1)

The George Institute for International Health

Camperdown, New South Wales, 2050, Australia

Location

Related Publications (4)

• Li W, Cornelius V, Finfer S, Venkatesh B, Billot L. Adaptive designs in critical care trials: a simulation study. BMC Med Res Methodol. 2023 Oct 18;23(1):236. doi: 10.1186/s12874-023-02049-6.

  PMID: 37853343 DERIVED

• Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

  PMID: 37526194 DERIVED

• NICE-SUGAR Study Investigators; Finfer S, Liu B, Chittock DR, Norton R, Myburgh JA, McArthur C, Mitchell I, Foster D, Dhingra V, Henderson WR, Ronco JJ, Bellomo R, Cook D, McDonald E, Dodek P, Hebert PC, Heyland DK, Robinson BG. Hypoglycemia and risk of death in critically ill patients. N Engl J Med. 2012 Sep 20;367(12):1108-18. doi: 10.1056/NEJMoa1204942.

  PMID: 22992074 DERIVED

• NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert 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 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.

  PMID: 19318384 DERIVED

MeSH Terms

Conditions

Hyperglycemia; Critical Illness; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Finfer, MBBS

  Royal North Shore Hospital

  STUDY CHAIR

• John Myburgh, MBBS

  St. George Hospital, Sydney

  PRINCIPAL INVESTIGATOR

• Rinaldo Bellomo, MBBS

  Austin Hospital, Melbourne Australia

  PRINCIPAL INVESTIGATOR

• Imogen Mitchell, MBBS

  The Canberra Hospital, ACT

  PRINCIPAL INVESTIGATOR

• Colin McArthur, MBBS

  Auckland Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

• Robyn Norton, Prof.

  The George Institute

  PRINCIPAL INVESTIGATOR

• Suzanne McEvoy, MBBS

  The George Institute

  PRINCIPAL INVESTIGATOR

• Leonie J Crampton, RN; CNS

  The George Institute

  PRINCIPAL INVESTIGATOR

• Julie Potter, RN

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

• Vinay Dhingra, MBBS

  Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

• Deborah Cook, MBBS

  St. Joseph's Hospital, Ontario

  PRINCIPAL INVESTIGATOR

• Paul Hebert, MBBS

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 29, 2009

Record last verified: 2009-01

Locations

AU (1)