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

April 1, 2020 updated by: University Hospital Muenster

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, 48149
        • Universitiy Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non consecutive patients presenting in the ER of the University Hospital in Muenster, Germany.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected sepsis

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.
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.
Non-Sepsis Patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of glycocalyx thickness with clinical course.
Time Frame: 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.).
At time of presentation in the ER.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of glycocalyx thickness with major events.
Time Frame: 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)
Hospital stay, an expected average of 4 weeks.
Correlation of glycocalyx thickness with 90-day mortality.
Time Frame: Up to 90 days.
Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ 90-day mortality.
Up to 90 days.
Correlation of glycocalyx thickness with subsequent organ failure.
Time Frame: 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).
Hospital stay, an expected average of 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Philipp Kümpers, MD, University Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (ACTUAL)

April 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDGE 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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