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

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ClinicalTrials.gov Identifier: NCT00288743
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : September 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. To determine potential factors associated with blood glucose control


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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

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00288743     History of Changes
Other Study ID Numbers: 2002/087
First Posted: February 8, 2006    Key Record Dates
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