Glycocalyx and Microcirculation in Sepsis

Study Overview
=================
Brief Summary
-----------------
The aim of this observative, prospective study with cross-sectional design is to explore possible correlations/associations between microcirculation parameters and sublingual endothelial glycocalyx in sepsis. Therefore, 30 critically ill septic patients and 10 healthy controls were enrolled.

Official Title
-----------------
Association of Sublingual Microcirculation Parameters and Endothelial Glycocalyx Dimensions in Resuscitated Sepsis: A Cross-sectional Study

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Microcirculation and Glycocalyx assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - septic ICU cohort: Sepsis (based on sepsis-3 criteria) ICU stay Inclusion Criteria - healthy controls: - Adult healthy individuals Exclusion Criteria (for all groups): Underage pregnancy oral mucosal inflammation or injury
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Septic patients<br>ICU patients with resuscitated sepsis, based on the sepsis-3 criteria. (n=30) | Other: Microcirculation and Glycocalyx assessment<br>* Non-invasive assessment of endothelial glycocalyx dimensions (PBR) and microcirculatory parameters (e.g. PPV, PVD, TVD, MFI)<br>|
| Healthy controls<br>Apparently healthy controls (n=10) | Other: Microcirculation and Glycocalyx assessment<br>* Non-invasive assessment of endothelial glycocalyx dimensions (PBR) and microcirculatory parameters (e.g. PPV, PVD, TVD, MFI)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between Perfused Boundary Region (PBR) and Microvascular Flow Index (MFI) measured sublingually | Glycocalyx thickness will be measured with PBR (in μm) and MFI will be assessed in points. Possible correlations at a given timepoint will be explored (e.g. Spearman's Correlation). | During ICU stay, an average of 2 days after sepsis onset | 
| Correlations between Perfused Boundary Region (PBR) and Proportion of Perfused Vessels (PPV) measured sublingually | Glycocalyx thickness will be measured with PBR (in μm) and PPV will be assessed in percentage. Possible correlations at a given timepoint will be explored (e.g. Spearman's Correlation). | During ICU stay, an average of 2 days after sepsis onset | 
| Correlations between Perfused Boundary Region (PBR) and Perfused Vessel Density (PVD) measured sublingually | Glycocalyx thickness will be measured with PBR (in μm) and PVD will be assessed in mm/mm^2. Possible correlations at a given timepoint will be explored (e.g. Spearman's Correlation). | During ICU stay, an average of 2 days after sepsis onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycocalyx, PBR, microcirculation