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

Phase 2

Completed

• Conditions: Critically Ill Patients

• Registration Number: NCT00288743
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study Completion: 2002-12
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To determine potential factors associated with blood glucose control

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium