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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Healthy Individuals | Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlycoCheck™-System | Other | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Patients with suspected sepsis
Patients without sepsis
Healthy individuals
Exclusion Criteria (for all groups):
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Non consecutive patients presenting in the ER of the University Hospital in Muenster, Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Kümpers, MD | University Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitiy Hospital Muenster | Münster | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41998704 | Derived | Scarbeck MM, Kunnemann MD, Hunkemoller AM, Drost CC, Lukasz A, Birkner M, Fobker M, Nofer JR, Vink H, Pavenstadt H, Kumpers P, Rovas A. Early detection of glycocalyx and microvascular damage in suspected sepsis in the emergency department: the EDGE study. Crit Care. 2026 Apr 17;30(1):241. doi: 10.1186/s13054-026-05989-9. |
| Label | URL |
|---|---|
| Description of GlycoCheck™- System | View source |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |