Continuous Glucose Monitoring in Critically Ill Patients - Full Text View

Purpose

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

Condition	Intervention
Critical Illness	Device: continuous subcutaneous glucose monitoring

Drug Information available for:

Insulin Dextrose Norepinephrine Norepinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

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

Further study details as provided by Medical University of Vienna:

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 ]

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 ]

Enrollment:	50
Study Start Date:	April 2005
Study Completion Date:	March 2007
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Continuous subcutaneous glucose monitoring in patients without shock	Device: continuous subcutaneous glucose monitoring continuous subcutaneous glucose monitoring for 72h
2: Active Comparator continuous subcutaneous glucose monitoring in patients with shock	Device: continuous subcutaneous glucose monitoring continuous subcutaneous glucose monitoring for 72h

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494455

Locations


Austria
	Medical University of Vienna
	Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators


Principal Investigator:	Ulrike Holzinger, MD	Medical University of Vienna, Department of Medicine III

More Information

Responsible Party:	Medical University of Vienna ( Dr. Ulrike Holzinger )
Study ID Numbers:	108/2005
First Received:	June 27, 2007
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00494455
Health Authority:	Austria: Ethikkommission