NCT00463645

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
Last Updated

June 6, 2007

Status Verified

April 1, 2007

First QC Date

April 19, 2007

Last Update Submit

June 5, 2007

Conditions

Interventions

microdialysisPROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Sepsis

Interventions

Microdialysis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DialysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Thomas R. Pieber, MD.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

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

Locations