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Sponsored by: |
Medical University of Vienna |
Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00494455 |
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 |
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 |
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
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Device: continuous subcutaneous glucose monitoring
continuous subcutaneous glucose monitoring for 72h
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2: Active Comparator
continuous subcutaneous glucose monitoring in patients with shock
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Device: continuous subcutaneous glucose monitoring
continuous subcutaneous glucose monitoring for 72h
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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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |||||
Medical University of Vienna | |||||
Vienna, Austria, 1090 |
Medical University of Vienna |
Principal Investigator: | Ulrike Holzinger, MD | Medical University of Vienna, Department of Medicine III |
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 |
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