- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00288743
Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study
December 19, 2007 updated by: University Hospital, Ghent
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ghent, Belgium, 9000
- University Hospital Ghent
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients
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Secondary Outcome Measures
Outcome Measure |
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To determine potential factors associated with blood glucose control
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sandra Oeyen, MD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Study Completion (Actual)
December 1, 2002
Study Registration Dates
First Submitted
February 7, 2006
First Submitted That Met QC Criteria
February 7, 2006
First Posted (Estimate)
February 8, 2006
Study Record Updates
Last Update Posted (Estimate)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 19, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002/087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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