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

This study has been completed.

First Received: September 13, 2005 Last Updated: January 27, 2009 History of Changes

Sponsor:	The George Institute
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

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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:

MedlinePlus related topics: Diabetes Medicines Hypoglycemia

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

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
Intensive Insulin therapy: Experimental Intensive Insulin therapy	Other: Intensive Insulin Therapy Maintain blood glucose 4.5 - 6.o mmol/L
Conventional Therapy: Active Comparator 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:

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.

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

Contacts and Locations

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by The George Institute

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert 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. Epub 2009 Mar 24.

Responsible Party:	The George Institute ( Simon Finfer )
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
Pathologic Processes
Glucose Metabolism Disorders

Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2010