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Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00463645
First received: April 19, 2007
Last updated: June 5, 2007
Last verified: April 2007
History of Changes

April 19, 2007
June 5, 2007
September 2005
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Complete list of historical versions of study NCT00463645 on ClinicalTrials.gov Archive Site
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Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients
An Open, Mono-Centre Trial to Investigate the Correlation Between the Interstitial and Arterial Blood Concentrations of Glucose During Subcutaneous Glucose Monitoring in Patients With Severe Sepsis at the Medical Intensive Care Unit

This is a mono-centre trial performed at the medical ICU at the Medical University Graz. There will be a study visit (V1) and a follow-up assessment (V2). In the study visit (V1) arterial blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination and with microperfusion for cytokine-measurement will be performed. The study visit will last for 26 hours starting with the insertion of two catheters in the abdominal subcutaneous tissue (one microdialysis- and one microperfusion catheter). The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlates to the arterial blood glucose concentration profile in patients with severe sepsis in the medical ICU.
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Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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Severe Sepsis
  • Procedure: microdialysis
  • Procedure: microperfusion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2006
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Inclusion Criteria:

  • Patients in the medical ICU fulfilling criteria for severe sepsis
  • Mechanical ventilation
  • Increased blood glucose levels ( > 120 mg/dL; > 6.7 mM), or requiring insulin treatment.
  • Age of patients in the range from 18 to 90 years.

Exclusion Criteria:

  • Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00463645
CM3_adipose
No
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Medical University of Graz
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Principal Investigator: Thomas R. Pieber, MD. Medical University of Graz
Medical University of Graz
April 2007

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