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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03126032
Other study ID # EDGE 001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 3, 2017
Est. completion date December 31, 2019

Study information

Verified date April 2020
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim of the study is to evaluate to what extent a glycocalyx damage measured in the ER in patients presenting with sepsis correlates with their clinical course and if it can be used as a clinical stratification tool and mortality predictor.

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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients with suspected sepsis

- 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 (for all groups):

- Underage persons

- Pregnant women

- Oral mucosal injuries

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Germany Universitiy Hospital Muenster Muenster

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of glycocalyx thickness with clinical course. Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm) will be correlated with patients' clinical course (e.g. with the use of SOFA score - pts.). At time of presentation in the ER.
Secondary Correlation of glycocalyx thickness with major events. Glycocalyx thickness (PBR, in µm) will be correlated with patients? major events (dialysis, intubation, ICU admission, death) Hospital stay, an expected average of 4 weeks.
Secondary Correlation of glycocalyx thickness with 90-day mortality. Glycocalyx thickness (PBR, in µm) will be correlated with patients? 90-day mortality. Up to 90 days.
Secondary Correlation of glycocalyx thickness with subsequent organ failure. Glycocalyx thickness (PBR, in µm) will be correlated with subsequent organ failure (e.g. kidney, lung, circulation). Hospital stay, an expected average of 4 weeks.
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