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

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.
 
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

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 8, 2006
Last Update Posted Date December 28, 2007
Study Start Date  ICMJE September 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
To determine potential factors associated with blood glucose control
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study
Official Title  ICMJE Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critically Ill Patients
Intervention  ICMJE Drug: to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 7, 2006)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288743
Other Study ID Numbers  ICMJE 2002/087
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandra Oeyen, MD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP