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

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT00463645
Collaborator
(none)
10
Enrollment
1
Location
4
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: microdialysis
  • Procedure: microperfusion

Study Design

Study Type:
Observational
Observational Model:
Defined Population
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
Study Start Date :
Sep 1, 2005
Actual Study Completion Date :
Jan 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00463645
    Other Study ID Numbers:
    • CM3_adipose
    First Posted:
    Apr 20, 2007
    Last Update Posted:
    Jun 6, 2007
    Last Verified:
    Apr 1, 2007
    Additional relevant MeSH terms:
    Sepsis

    Study Results

    No Results Posted as of Jun 6, 2007