Early Detection of Glycocalyx Damage in Emergency Room Patients
NCT ID: NCT03126032
Last Updated: 2020-04-02
Study Results
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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COMPLETED
260 participants
OBSERVATIONAL
2017-04-03
2019-12-31
Brief Summary
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The study will focus on the changes of the microcirculation and how they correlate with the macrocirculation, as well as microbiologic parameters. In the study will participate ca. 300 patients with sepsis, as well as 30 patients without sepsis and 30 healthy individuals.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with suspected sepsis
Patients presenting in the Emergency Room (ER) with the clinical suspicion of infection/sepsis.
Evaluation of the glycocalyx damage with the use of GlycoCheck™-System, as well as blood sample at presentation, day 1 and day 7 of their hospital stay.
GlycoCheck™-System
Consecutive, sublingual measurements of endothelial glycocalyx with GlycoCheck™-System will be obtained at presentation, as well as during the inpatient treatment of the patients with suspected sepsis.
Blood sample will be drawn in all groups at time of assessment. Besides that, in patients with suspected sepsis blood samples will be drawn for further microbiologic and laboratory analysis at day 1 and day 7 of their hospital stay.
Non-Sepsis Patients
Patients presenting in the Emergency Room with other conditions apart from infection/sepsis.
Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation.
GlycoCheck™-System
Consecutive, sublingual measurements of endothelial glycocalyx with GlycoCheck™-System will be obtained at presentation, as well as during the inpatient treatment of the patients with suspected sepsis.
Blood sample will be drawn in all groups at time of assessment. Besides that, in patients with suspected sepsis blood samples will be drawn for further microbiologic and laboratory analysis at day 1 and day 7 of their hospital stay.
Healthy Individuals
Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation.
GlycoCheck™-System
Consecutive, sublingual measurements of endothelial glycocalyx with GlycoCheck™-System will be obtained at presentation, as well as during the inpatient treatment of the patients with suspected sepsis.
Blood sample will be drawn in all groups at time of assessment. Besides that, in patients with suspected sepsis blood samples will be drawn for further microbiologic and laboratory analysis at day 1 and day 7 of their hospital stay.
Interventions
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GlycoCheck™-System
Consecutive, sublingual measurements of endothelial glycocalyx with GlycoCheck™-System will be obtained at presentation, as well as during the inpatient treatment of the patients with suspected sepsis.
Blood sample will be drawn in all groups at time of assessment. Besides that, in patients with suspected sepsis blood samples will be drawn for further microbiologic and laboratory analysis at day 1 and day 7 of their hospital stay.
Eligibility Criteria
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Inclusion Criteria
* Adult patients presenting to the ER with the clinical suspicion of infection
* Indication for hospital admission
Patients without sepsis
* Adult patients presenting to the ER with other conditions apart from sepsis/infection.
Healthy individuals
* Adult healthy individuals.
Exclusion Criteria
* Pregnant women
* Oral mucosal injuries
18 Years
ALL
Yes
Sponsors
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University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Philipp Kümpers, MD
Role: PRINCIPAL_INVESTIGATOR
University Muenster
Locations
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Universitiy Hospital Muenster
Münster, , Germany
Countries
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Related Links
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Description of GlycoCheck™- System
Other Identifiers
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EDGE 001
Identifier Type: -
Identifier Source: org_study_id
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