Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients
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
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2005
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedJune 6, 2007
April 1, 2007
April 19, 2007
June 5, 2007
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Graz
Graz, Styria, 8036, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas R. Pieber, MD.
Medical University of Graz
Study Design
- Study Type
- observational
- Observational Model
- DEFINED POPULATION
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 19, 2007
First Posted
April 20, 2007
Study Start
September 1, 2005
Study Completion
January 1, 2006
Last Updated
June 6, 2007
Record last verified: 2007-04