Early Detection of Glycocalyx Damage in Emergency Room Patients

University Hospital Muenster260 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

Sepsis SIRS

Interventions

GlycoCheck™-SystemOTHER

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitiy Hospital Muenster

Münster, Germany

Outcomes

Primary Outcomes

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.).

Time frame: At time of presentation in the ER.

Secondary Outcomes

Correlation of glycocalyx thickness with major events.

Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ major events (dialysis, intubation, ICU admission, death)

Time frame: 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.

Time frame: 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).

Time frame: Hospital stay, an expected average of 4 weeks.

Data from ClinicalTrials.gov

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