Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients - Full Text View

Sponsored by:	Medical University of Graz
Information provided by:	Medical University of Graz
ClinicalTrials.gov Identifier:	NCT00463645

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

MedlinePlus related topics: Sepsis

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
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

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, Styria
Medical University Graz
Graz, Styria, Austria, 8036

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator:

Thomas R. Pieber, MD.

Medical University Graz

More 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

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

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009