NCT00288743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

February 7, 2006

Last Update Submit

December 19, 2007

Conditions

Critically Ill Patients

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • To determine potential factors associated with blood glucose control

Interventions

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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with diabetic ketoacidosis
  • Cardiac surgical patients
  • Patients transferred from other hospitals
  • Other study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Sandra Oeyen, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 8, 2006

Study Start

September 1, 2002

Study Completion

December 1, 2002

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)