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KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115479
First Posted: June 23, 2005
Last Update Posted: May 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Novo Nordisk A/S
Information provided by:
Katholieke Universiteit Leuven
  Purpose
In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Condition Intervention Phase
Critical Illness Drug: intensive insulin therapy to maintain normoglycemia Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • mortality

Secondary Outcome Measures:
  • mechanical ventilatory support-dependency
  • stay in Intensive Care Unit (ICU)
  • stay in hospital
  • organ failure
  • morbidity
  • a long-term follow up is planned to take place 6 and 12 months after hospital discharge

Estimated Enrollment: 1200
Study Start Date: March 2002
Estimated Study Completion Date: June 2005
Detailed Description:
In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults admitted to ICU and anticipated to require intensive care for at least a few days

Exclusion Criteria:

  • Expected short ICU stay
  • Therapy restricted upon admission
  • Surgical ICU patients
  • Other studies
  • Below 18 years
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115479


Locations
Belgium
Catholic University of Leuven, University Hospital Gasthuisberg
Leuven, Belgium, B-3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Fund for Scientific Research, Flanders, Belgium
Novo Nordisk A/S
Investigators
Principal Investigator: Greet H Van den Berghe, MD, PhD K.U.Leuven
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00115479     History of Changes
Other Study ID Numbers: S18630
FWO grant number G.0278.03
KULeuven OT/03/56
First Submitted: June 22, 2005
First Posted: June 23, 2005
Last Update Posted: May 4, 2006
Last Verified: June 2005

Keywords provided by Katholieke Universiteit Leuven:
critical illness
intensive care
outcome
insulin
blood glucose

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs