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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00288743
First received: February 7, 2006
Last updated: December 19, 2007
Last verified: December 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00288743     History of Changes
Other Study ID Numbers: 2002/087
Study First Received: February 7, 2006
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014