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Completed

NCT Number: NCT03126032

Early Detection of Glycocalyx Damage in Emergency Room Patients

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms SIRS Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitiy Hospital Muenster

Münster, 48149, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GlycoCheck™-System

Other

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.

Primary outcomes

  1. 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.).

Secondary outcomes

  1. 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)

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Acronym: EDGE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2017
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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