Continuous Glucose Monitoring in Critically Ill Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 27, 2007

Last Updated Date

February 19, 2008

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock [ Time Frame: 72h ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00494455 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation [ Time Frame: 72h ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Continuous Glucose Monitoring in Critically Ill Patients

Official Title ^†

Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy

Brief Summary

The purpose of this study is to determine whether subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.

Detailed Description

Hyperglycemia is is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. Continuous glucose measurement would facilitate blood glucose control in critically ill patients. Numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. Studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an ICU-setting are rare. Therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Critical Illness

Intervention ^†

Device: continuous subcutaneous glucose monitoring

Study Arms / Comparison Groups

Active Comparator: Continuous subcutaneous glucose monitoring in patients without shock
Active Comparator: continuous subcutaneous glucose monitoring in patients with shock

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

March 2007

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Admitted patients expected to stay >48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock.

Exclusion Criteria:

Admitted patients expected to stay <48h

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Austria

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00494455

Responsible Party

Dr. Ulrike Holzinger, Medical University of Vienna

Secondary IDs ^††

Study Sponsor ^†

Medical University of Vienna

Collaborators ^††

Investigators ^†

Principal Investigator:

Ulrike Holzinger, MD

Medical University of Vienna, Department of Medicine III

Information Provided By

Medical University of Vienna

Verification Date

June 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.