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

Primary Purpose

Critically Ill Patients

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Critically Ill Patients

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Ghent

Outcomes

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

Full Information

NCT ID

NCT00288743

First Posted

February 7, 2006

Last Updated

December 19, 2007

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00288743

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

September 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critically Ill Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients

Secondary Outcome Measure Information:

Title

To determine potential factors associated with blood glucose control

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra Oeyen, MD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Learn more about this trial

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

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