SepsisEDGENCT03126032
Early Detection of Glycocalyx Damage in Emergency Room Patients
An observational study of Sepsis and SIRS, run by University Hospital Muenster at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- GlycoCheck™-System
- How many people
- 260 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non consecutive patients presenting in the ER of the University Hospital in Muenster, Germany.
Who may be able to join
- 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.
Who cannot join
- Underage persons
- Pregnant women
- Oral mucosal injuries
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- GlycoCheck™-System
- Keywords
- Sepsis, SIRS, Glycocalyx, Glycocheck™-System, Infection
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycoCheck™-SystemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: GlycoCheck™-System | |
| 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. Receives: Other: GlycoCheck™-System | |
| Healthy Individuals | Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation. Receives: Other: GlycoCheck™-System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: At time of presentation in the ER.
Secondary outcomes (3)
Correlation of glycocalyx thickness with major events.
Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ major events (dialysis, intubation, ICU admission, death)
Measured: Hospital stay, an expected average of 4 weeks.
Correlation of glycocalyx thickness with 90-day mortality.
Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ 90-day mortality.
Measured: Up to 90 days.
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).
Measured: Hospital stay, an expected average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start3 Apr 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Kümpers, MD, Principal investigator, University Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126032
- Sponsor's protocol ID
- EDGE 001
- Acronym
- EDGE
- Status last verified
- Apr 2020
- First submitted
- 20 Feb 2017
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scarbeck MM, Kunnemann MD, Hunkemoller AM, Drost CC, Lukasz A, Birkner M, Fobker M, Nofer JR, Vink H, Pavenstadt H, Kumpers P, Rovas A. Early detection of glycocalyx and microvascular damage in suspected sepsis in the emergency department: the EDGE study. Crit Care. 2026 Apr 17;30(1):241. doi: 10.1186/s13054-026-05989-9.
PubMed 41998704
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Glycocalyx Damage in Emergency Room Patients
- ClinicalTrials.gov ID
- NCT03126032
- Acronym / sponsor ID
- EDGE / EDGE 001
- Keywords
- Sepsis, SIRS, Glycocalyx, Glycocheck™-System, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected sepsis | – | Other: GlycoCheck™-SystemPatients 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 | – | Other: GlycoCheck™-SystemPatients 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 | – | Other: GlycoCheck™-SystemEvaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non consecutive patients presenting in the ER of the University Hospital in Muenster, Germany.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Underage persons
- Pregnant women
- Oral mucosal injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycoCheck™-SystemConsecutive, 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. | Other | Healthy Individuals, Non-Sepsis Patients, Patients with suspected sepsis |
Primary outcome
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.).
3 secondary outcomes
Correlation of glycocalyx thickness with major events.
Time frame: Hospital stay, an expected average of 4 weeks.
Correlation of glycocalyx thickness with 90-day mortality.
Time frame: Up to 90 days.
Correlation of glycocalyx thickness with subsequent organ failure.
Time frame: Hospital stay, an expected average of 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Derived from this study: PubMed 41998704Scarbeck MM, Kunnemann MD, Hunkemoller AM, Drost CC, Lukasz A, Birkner M, Fobker M, Nofer JR, Vink H, Pavenstadt H, Kumpers P, Rovas A. Early detection of glycocalyx and microvascular damage in suspected sepsis in the emergency department: the EDGE study. Crit Care. 2026 Apr 17;30(1):241. doi: 10.1186/s13054-026-05989-9.
- Description of GlycoCheck™- SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Kümpers, MD principal investigator
University Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and SIRS, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of glycocalyx thickness with clinical course. (time frame: At time of presentation in the ER.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.