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

• Conditions: Endothelial Dysfunction; Septic Shock; Sepsis
• Interventions: Other: Endothelial Glycocalyx

• Registration Number: NCT03847493
• Lead Sponsor: University Hospital Muenster

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Study Start: 2019-04-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspected sepsis	Endothelial Glycocalyx	Patients admitted in the ICU with the clinical suspicion of infection/sepsis.
Non-sepsis Patients (control group)	Endothelial Glycocalyx	Patients admitted in the ICU with other conditions apart from infection/sepsis.

Primary Outcome Measures

Name	Time	Method
Predictive value of glycocalyx thickness regarding mortality.	Hospital stay, an expected time of 4 weeks.	Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm).
Predictive value of glycocalyx thickness regarding clinical course.	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).

Secondary Outcome Measures

Name	Time	Method
Correlation of glycocalyx thickness with disease severity.	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)

Trial Locations

Locations (1)

Universitiy Hospital Muenster; 🇩🇪 Muenster, Germany