Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death (ASGARD)

November 4, 2022 updated by: University Hospital Muenster

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.

Description

Inclusion Criteria:

  • ICU patients admitted to the ICU with the clinican suspicion of sepsis/septic shock.

Exclusion Criteria:

  • Underage persons, pregnant women, patients with inflammation or trauma of sublingual mucosa.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with suspected sepsis
Patients admitted in the ICU with the clinical suspicion of infection/sepsis.
Other: Endothelial Glycocalyx
Non-invasive assessment of endothelial glycocalyx dimensions.
Non-sepsis Patients (control group)
Patients admitted in the ICU with other conditions apart from infection/sepsis.
Other: Endothelial Glycocalyx
Non-invasive assessment of endothelial glycocalyx dimensions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Hospital stay, an expected time of 4 weeks.
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).
Hospital stay, an expected time of 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of glycocalyx thickness with disease severity.
Time Frame: Hospital stay, an expected time of 4 weeks.
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)
Hospital stay, an expected time of 4 weeks.

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

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 15, 2019

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASGARD

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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