Early Detection of Glycocalyx Damage in Emergency Room Patients

Study Overview
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Brief Summary
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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.

Official Title
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Early Detection of Glycocalyx Damage in Emergency Room Patients

Conditions
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Sepsis, SIRS

Intervention / Treatment
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* Other: GlycoCheck™-System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspected sepsis<br>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. | Other: GlycoCheck™-System<br>* 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.<br>|
| Non-Sepsis Patients<br>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. | Other: GlycoCheck™-System<br>* 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.<br>|
| Healthy Individuals<br>Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation. | Other: GlycoCheck™-System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, SIRS, Glycocalyx, Glycocheck™-System, Infection