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

Sepsis Clinical Trial

— ASGARD  

Official title:

Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death - the ASGARD Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03847493
• Other study ID #: ASGARD
• Status: Active, not recruiting
• Start date: April 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Therefore, the enrollment of ca 100 ICU patients is planned.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Sepsis
• Septic Shock
• Shock, Septic

Intervention

Other:
• Endothelial Glycocalyx
Non-invasive assessment of endothelial glycocalyx dimensions.

Locations

Country	Name	City	State
Germany	Universitiy Hospital Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Hospital stay, an expected time of 4 weeks.
Primary	Predictive value of glycocalyx thickness regarding mortality.	Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm).	Hospital stay, an expected time of 4 weeks.
Secondary	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)	Hospital stay, an expected time of 4 weeks.