SepsisASGARDNCT03847493
Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death
An observational study of Sepsis and Septic Shock, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The aim of this observative, prospective study is to evaluate if and to what extent glycocalyx damage/microcirculation data at admission in the ICU as well as during ICU stay can be predictive of mortality and clinical course in patients presenting with the suspicion of sepsis/septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Endothelial Dysfunction
- What is being tested?
- Endothelial Glycocalyx
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2019to 31 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.
Who may be able to join
- ICU patients admitted to the ICU with the clinican suspicion of sepsis/septic shock.
Who cannot join
- Underage persons, pregnant women, patients with inflammation or trauma of sublingual mucosa.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death - the ASGARD Study
The aim of this observative, prospective study is to evaluate if and to what extent glycocalyx damage/microcirculation data at admission in the ICU as well as during ICU stay can be predictive of mortality and clinical course in patients presenting with the suspicion of sepsis/septic shock. Therefore, the enrollment of ca 100 ICU patients is planned.
- Conditions
- Sepsis, Septic Shock, Endothelial Dysfunction
- Being tested
- Endothelial Glycocalyx
- Keywords
- perfused boundary region, PBR, Sepsis, endothelial glycocalyx, ICU
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial GlycocalyxOther
Non-invasive assessment of endothelial glycocalyx dimensions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected sepsis | Patients admitted in the ICU with the clinical suspicion of infection/sepsis. Receives: Other: Endothelial Glycocalyx | |
| Non-sepsis Patients (control group) | Patients admitted in the ICU with other conditions apart from infection/sepsis. Receives: Other: Endothelial Glycocalyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of glycocalyx thickness regarding clinical course.
Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm). Clinical course will be estimated with the use of e.g. Sequential Organ Failure Assessment (SOFA) score (in points).
Measured: Hospital stay, an expected time of 4 weeks.
Predictive value of glycocalyx thickness regarding mortality.
Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm).
Measured: Hospital stay, an expected time of 4 weeks.
Secondary outcomes (1)
Correlation of glycocalyx thickness with disease severity.
Glycocalyx thickness will be measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in μm). Disease severity will be assessed with ICU scores (e.g. SOFA Score - pts)
Measured: Hospital stay, an expected time 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 posted20 Feb 2019
- Study start15 Apr 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Kümpers, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847493
- Sponsor's protocol ID
- ASGARD
- Acronym
- ASGARD
- Status last verified
- May 2022
- First submitted
- 14 Feb 2019
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death - the ASGARD Study
- ClinicalTrials.gov ID
- NCT03847493
- Acronym / sponsor ID
- ASGARD / ASGARD
- Conditions
- Sepsis, Septic Shock, Endothelial Dysfunction
- Keywords
- perfused boundary region, PBR, Sepsis, endothelial glycocalyx, ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Feb 2019 (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.
The aim of this observative, prospective study is to evaluate if and to what extent glycocalyx damage/microcirculation data at admission in the ICU as well as during ICU stay can be predictive of mortality and clinical course in patients presenting with the suspicion of sepsis/septic shock. Therefore, the enrollment of ca 100 ICU patients is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected sepsis | – | Other: Endothelial GlycocalyxPatients admitted in the ICU with the clinical suspicion of infection/sepsis. |
| Non-sepsis Patients (control group) | – | Other: Endothelial GlycocalyxPatients admitted in the ICU with other conditions apart from infection/sepsis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.
Key inclusion criteria (1 listed)
- ICU patients admitted to the ICU with the clinican suspicion of sepsis/septic shock.
Key exclusion criteria (1 listed)
- Underage persons, pregnant women, patients with inflammation or trauma of sublingual mucosa.
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 |
|---|---|---|
| Endothelial GlycocalyxNon-invasive assessment of endothelial glycocalyx dimensions. | Other | Non-sepsis Patients (control group), Patients with suspected sepsis |
Primary outcome
Predictive value of glycocalyx thickness regarding clinical course.
Time frame: Hospital stay, an expected time of 4 weeks.
Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm). Clinical course will be estimated with the use of e.g. Sequential Organ Failure Assessment (SOFA) score (in points).
Predictive value of glycocalyx thickness regarding mortality.
Time frame: Hospital stay, an expected time of 4 weeks.
Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm).
1 secondary outcome
Correlation of glycocalyx thickness with disease severity.
Time frame: Hospital stay, an expected time of 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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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 Hospital 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 Septic Shock, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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?
Results are not available in the source record.
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?
Predictive value of glycocalyx thickness regarding clinical course. (time frame: Hospital stay, an expected time of 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2022.