Continuous Glucose Monitoring in Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00494455
First received: June 27, 2007
Last updated: February 19, 2008
Last verified: June 2007

June 27, 2007
February 19, 2008
April 2005
April 2006   (final data collection date for primary outcome measure)
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 ]
correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock [ Time Frame: 72h ]
Complete list of historical versions of study NCT00494455 on ClinicalTrials.gov Archive Site
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 ]
influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation [ Time Frame: 72h ]
Not Provided
Not Provided
 
Continuous Glucose Monitoring in Critically Ill Patients
Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Critical Illness
Device: continuous subcutaneous glucose monitoring
continuous subcutaneous glucose monitoring for 72h
Other Name: CGMS (Medtronic)
  • Active Comparator: 1
    Continuous subcutaneous glucose monitoring in patients without shock
    Intervention: Device: continuous subcutaneous glucose monitoring
  • Active Comparator: 2
    continuous subcutaneous glucose monitoring in patients with shock
    Intervention: Device: continuous subcutaneous glucose monitoring
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2007
April 2006   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00494455
108/2005
Yes
Dr. Ulrike Holzinger, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Ulrike Holzinger, MD Medical University of Vienna, Department of Medicine III
Medical University of Vienna
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP