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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
  Purpose

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.


Condition Intervention
Severe Sepsis
 Procedure: microdialysis
Procedure: microperfusion

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Sepsis
Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Estimated Enrollment: 10
Study Start Date: September 2005
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463645

Locations
Austria
Medical University Graz
Graz, Styria, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas R. Pieber, MD. Medical University of Graz
  More Information

Additional Information:
background information about the overall project  This link exits the ClinicalTrials.gov site
background on the investigators and study site  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00463645     History of Changes
Other Study ID Numbers: CM3_adipose
Study First Received: April 19, 2007
Last Updated: June 5, 2007
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013