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Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288743
First Posted: February 8, 2006
Last Update Posted: December 28, 2007
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.
Information provided by:
University Hospital, Ghent
  Purpose
There is a growing body of evidence in the literature regarding the adverse effects of hyperglycemia in critically ill patients. To target and maintain better blood glucose regulation we implemented an insulin protocol with target blood glucose levels between 81-110 mg/dL.

Condition Intervention Phase
Critically Ill Patients Drug: to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL. Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients

Secondary Outcome Measures:
  • To determine potential factors associated with blood glucose control

Estimated Enrollment: 30
Study Start Date: September 2002
Study Completion Date: December 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgical or medical critically ill patients
  • An expected ICU-stay of more than 72 hours
  • Age > 16 years
  • Need for insulin therapy
  • Patients must have an arterial line

Exclusion Criteria:

  • Patients who did not respond to the inclusion criteria
  • Patients with diabetic ketoacidosis
  • Cardiac surgical patients
  • Patients transferred from other hospitals
  • Other study enrollment
  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): NCT00288743


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Sandra Oeyen, MD University Hospital, Ghent
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00288743     History of Changes
Other Study ID Numbers: 2002/087
First Submitted: February 7, 2006
First Posted: February 8, 2006
Last Update Posted: December 28, 2007
Last Verified: December 2007

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