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Continuous Glucose Monitoring in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00494455
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : February 29, 2008
Sponsor:
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment
Critical Illness Device: continuous subcutaneous glucose monitoring

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy
Study Start Date : April 2005
Primary Completion Date : April 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Continuous subcutaneous glucose monitoring in patients without shock
Device: continuous subcutaneous glucose monitoring
continuous subcutaneous glucose monitoring for 72h
Other Name: CGMS (Medtronic)
Active Comparator: 2
continuous subcutaneous glucose monitoring in patients with shock
Device: continuous subcutaneous glucose monitoring
continuous subcutaneous glucose monitoring for 72h
Other Name: CGMS (Medtronic)



Primary Outcome Measures :
  1. correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock [ Time Frame: 72h ]

Secondary Outcome Measures :
  1. influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation [ Time Frame: 72h ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ulrike Holzinger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00494455     History of Changes
Other Study ID Numbers: 108/2005
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: February 29, 2008
Last Verified: June 2007

Keywords provided by Medical University of Vienna:
critical illness
hyperglycemia
intensive insulin therapy
glucose monitoring
shock

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes