Sepsis, SIRS
Conditions
Keywords
Sepsis, SIRS, Glycocalyx, Glycocheck™-System, Infection
Brief 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.
Interventions
OTHERGlycoCheck™-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.
Sponsors
University Hospital Muenster
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of glycocalyx thickness with clinical course. | At time of presentation in the ER. | 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.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of glycocalyx thickness with major events. | Hospital stay, an expected average of 4 weeks. | Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ major events (dialysis, intubation, ICU admission, death) |
| Correlation of glycocalyx thickness with 90-day mortality. | Up to 90 days. | Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ 90-day mortality. |
| Correlation of glycocalyx thickness with subsequent organ failure. | Hospital stay, an expected average of 4 weeks. | Glycocalyx thickness (PBR, in µm) will be correlated with subsequent organ failure (e.g. kidney, lung, circulation). |
Countries
Germany
Outcome results
None listed