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

NCT ID: NCT00463645

Last Updated: 2007-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Sepsis

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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microdialysis

Intervention Type PROCEDURE

microperfusion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Principal Investigators

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Thomas R. Pieber, MD.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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CM3_adipose

Identifier Type: -

Identifier Source: org_study_id