- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00463645
Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients
June 5, 2007 updated by: Medical University of Graz
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Styria
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Graz, Styria, Austria, 8036
- Medical University Graz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas R. Pieber, MD., Medical University of Graz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
April 19, 2007
First Submitted That Met QC Criteria
April 19, 2007
First Posted (Estimate)
April 20, 2007
Study Record Updates
Last Update Posted (Estimate)
June 6, 2007
Last Update Submitted That Met QC Criteria
June 5, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM3_adipose
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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