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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04644302
Other study ID # FNHK_IGS_8144
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date July 1, 2021

Study information

Verified date September 2021
Source University Hospital Hradec Kralove
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course


Description:

This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation (sublingual area video recordings and biochemical parameters of endothelial cells activation and damage) endothelial glycocalyx (sublingual area video recordings and biochemical parameter of glycocalyx degradation), and clinical course.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult - ICU admission due to sepsis with organ failure - need for organ support therapy (mechanical ventilation, CRRT, ECMO) - clinical and/or laboratory signs of circulatory instability Exclusion Criteria: - family withdrawal/disagreement - death within three days from ICU admission

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
microcirculation recording
non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Králové Trebeš

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in Proportion of Perfused Vessels (PPV) parameter PPV describes microcirculation dysfunction 1st, 2nd and 3rd day
Primary change in Syndecan-1 serum concentration Syndecan-1 is a marker of endothelial glycocalyx 1st, 2nd and 3rd day
Secondary change in albuminuria albuminuria is a marker of glomerular endothelial cells dysfunction 1st, 2nd and 3rd day
Secondary mortality in 28 days mortality in 28 days from ICU admission 30 days
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