Continuous Glucose Monitoring in Critically Ill Patients
| Tracking Information | |||||
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| First Received Date ICMJE | June 27, 2007 | ||||
| Last Updated Date | February 19, 2008 | ||||
| Start Date ICMJE | April 2005 | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ICMJE |
correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock [ Time Frame: 72h ] | ||||
| Change History | Complete list of historical versions of study NCT00494455 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ICMJE |
influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation [ Time Frame: 72h ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Continuous Glucose Monitoring in Critically Ill Patients | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Critical Illness | ||||
| Intervention ICMJE | Device: continuous subcutaneous glucose monitoring
continuous subcutaneous glucose monitoring for 72h
Other Name: CGMS (Medtronic) |
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| Study Arm (s) |
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| Publications * | Holzinger U, Warszawska J, Kitzberger R, Herkner H, Metnitz PG, Madl C. Impact of shock requiring norepinephrine on the accuracy and reliability of subcutaneous continuous glucose monitoring. Intensive Care Med. 2009 Aug;35(8):1383-9. Epub 2009 Apr 7. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00494455 | ||||
| Other Study ID Numbers ICMJE | 108/2005 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Ulrike Holzinger, Medical University of Vienna | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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