Early Detection of Glycocalyx Damage in Emergency Room Patients (EDGE)

University Hospital Muenster

Status: Completed

Conditions: SIRS; Sepsis

Treatments: Other: GlycoCheck™-System

Study type: Observational

Funder types: Other

Identifiers

NCT03126032

EDGE 001

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

260 participants in 3 patient groups

Patients with suspected sepsis

Description:

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.

Treatment:

Other: GlycoCheck™-System

Non-Sepsis Patients

Description:

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.

Treatment:

Other: GlycoCheck™-System

Healthy Individuals

Description:

Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation.

Treatment:

Other: GlycoCheck™-System