Early Detection of Glycocalyx Damage in Emergency Room Patients

Sepsis Clinical Trial

— EDGE  

Official title:

Early Detection of Glycocalyx Damage in Emergency Room Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126032
• Other study ID #: EDGE 001
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• SIRS

Intervention

Other:
• GlycoCheck™-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.

Locations

Country	Name	City	State
Germany	Universitiy Hospital Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.

External Links

•   Description of GlycoCheck™- System