Early Detection of Glycocalyx Damage in Emergency Room Patients

Completed

• Conditions: Sepsis; SIRS
• Interventions: Other: GlycoCheck™-System

• Registration Number: NCT03126032
• Lead Sponsor: University Hospital Muenster

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-20
• Study Start: 2017-04-03
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Sepsis Patients	GlycoCheck™-System	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.
Patients with suspected sepsis	GlycoCheck™-System	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.
Healthy Individuals	GlycoCheck™-System	Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Universitiy Hospital Muenster; 🇩🇪 Muenster, Germany