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NCT00463645 Clinical Trial

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

Severe Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00463645
Other study ID # CM3_adipose
Secondary ID
Status Completed
Phase N/A
First received April 19, 2007
Last updated June 5, 2007
Start date September 2005
Est. completion date January 2006

Study information
Verified date April 2007
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• microdialysis

• microperfusion

Locations
Country Name City State
Austria Medical University Graz Graz Styria

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

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