Early Detection of Glycocalyx Damage in Emergency Room Patients
EDGE
1 other identifier
observational
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedStudy Start
First participant enrolled
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 2, 2020
April 1, 2020
2.7 years
February 20, 2017
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Correlation of glycocalyx thickness with major events.
Hospital stay, an expected average of 4 weeks.
Correlation of glycocalyx thickness with 90-day mortality.
Up to 90 days.
Correlation of glycocalyx thickness with subsequent organ failure.
Hospital stay, an expected average of 4 weeks.
Study Arms (3)
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.
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.
Healthy Individuals
Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation.
Interventions
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.
Eligibility Criteria
Non consecutive patients presenting in the ER of the University Hospital in Muenster, Germany.
You may qualify if:
- 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.
You may not qualify if:
- Underage persons
- Pregnant women
- Oral mucosal injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitiy Hospital Muenster
Münster, 48149, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Kümpers, MD
University Muenster
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
April 24, 2017
Study Start
April 3, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
April 2, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share