Glycocalyx and Microcirculation in Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960307
• Other study ID #: IDF_SDF
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: May 2019
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• Microcirculation and Glycocalyx assessment
Non-invasive assessment of endothelial glycocalyx dimensions (PBR) and microcirculatory parameters (e.g. PPV, PVD, TVD, MFI)

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	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
Primary	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
Primary	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