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

NCT00220987 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6104

Last updated 2009-01-29

No results posted yet for this study

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

Interventions

OTHER

Intensive Insulin Therapy

Maintain blood glucose 4.5 - 6.o mmol/L

OTHER

Conventional Insulin therapy

Maintain blood glucose 8-10mmol/L

Sponsors & Collaborators

  • Australian and New Zealand Intensive Care Society Clinical Trials Group

    collaborator NETWORK
  • Canadian Critical Care Trials Group

    collaborator OTHER
  • National Health and Medical Research Council, Australia

    collaborator OTHER
  • Health Research Council, New Zealand

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • The George Institute

    lead OTHER

Principal Investigators

  • Simon Finfer, MBBS · Royal North Shore Hospital

  • John Myburgh, MBBS · St. George Hospital, Sydney

  • Rinaldo Bellomo, MBBS · Austin Hospital, Melbourne Australia

  • Imogen Mitchell, MBBS · The Canberra Hospital, ACT

  • Colin McArthur, MBBS · Auckland Hospital, New Zealand

  • Robyn Norton, Prof. · The George Institute

  • Suzanne McEvoy, MBBS · The George Institute

  • Leonie J Crampton, RN; CNS · The George Institute

  • Julie Potter, RN · Royal North Shore Hospital

  • Vinay Dhingra, MBBS · Vancouver General Hospital

  • Deborah Cook, MBBS · St. Joseph's Hospital, Ontario

  • Paul Hebert, MBBS · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00220987 on ClinicalTrials.gov