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NCT00288743 Clinical Trial

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

Critically Ill Patients Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00288743
Other study ID # 2002/087
Secondary ID
Status Completed
Phase Phase 2
First received February 7, 2006
Last updated December 19, 2007
Start date September 2002
Est. completion date December 2002

Study information
Verified date December 2007
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients
Secondary To determine potential factors associated with blood glucose control
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