Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Australian and New Zealand Intensive Care Society Clinical Trials Group
Canadian Critical Care Trials Group
National Health and Medical Research Council, Australia
Health Research Council, New Zealand
University of British Columbia
Information provided by:
The George Institute
ClinicalTrials.gov Identifier:
NCT00220987
First received: September 13, 2005
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Hyperglycemia
Critical Illness
Other: Intensive Insulin Therapy
Other: Conventional Insulin therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by The George Institute:

Primary Outcome Measures:
  • all-cause mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary outcomes, also determined over the same period of 90 days include: [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • Length of intensive care unit stay; [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Length of hospital stay; [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
  • The need for organ support (inotropes, renal replacement therapy and positive pressure ventilation); [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
  • Incidence of blood stream infections; [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
  • Incidence and severity of hypoglycaemia; [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
  • extended glasgow outcome score [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 6104
Study Start Date: April 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive Insulin therapy
Intensive Insulin therapy
Other: Intensive Insulin Therapy
Maintain blood glucose 4.5 - 6.o mmol/L
Active Comparator: Conventional Therapy
conventional insulin therapy
Other: Conventional Insulin therapy
Maintain blood glucose 8-10mmol/L

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are eligible for INCLUSION in the study if ALL the following criteria are met:

    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.

Exclusion Criteria:

Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:

  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 state.
  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 recovery.
  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 admission.

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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220987

Locations
Australia, New South Wales
The George Institute for International Health
Camperdown, New South Wales, Australia, 2050
Sponsors and Collaborators
The George Institute
Australian and New Zealand Intensive Care Society Clinical Trials Group
Canadian Critical Care Trials Group
National Health and Medical Research Council, Australia
Health Research Council, New Zealand
University of British Columbia
Investigators
Study Chair: Simon Finfer, MBBS Royal North Shore Hospital
Principal Investigator: 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
  More Information

Additional Information:
No publications provided by The George Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Simon Finfer, The George Institute
ClinicalTrials.gov Identifier: NCT00220987     History of Changes
Obsolete Identifiers: NCT00175331
Other Study ID Numbers: GI-IAT-NIC-G, NHMRC GRANT - 293201
Study First Received: September 13, 2005
Last Updated: January 27, 2009
Health Authority: Australia: National Health and Medical Research Council
New Zealand: Health Research Council
Canada: Canadian Institutes for Health Research

Keywords provided by The George Institute:
Hyperglycemia in the critically ill patient
Intensive Insulin Therapy
Conventional insulin therapy
Hypoglycaemia

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014