Circulatory Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis

Completed

• Conditions: Viral Pneumonia; Sepsis
• Interventions: Diagnostic Test: microcirculation recording

• Registration Number: NCT04644302
• Lead Sponsor: University Hospital Hradec Kralove

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-11-25
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID sepsis	microcirculation recording	Patients admitted to ICU with sepsis of COVID origin
non-COVID sepsis	microcirculation recording	Patients admitted to ICU with sepsis of non-COVID origin

Primary Outcome Measures

Name	Time	Method
change in Proportion of Perfused Vessels (PPV) parameter	1st, 2nd and 3rd day	PPV describes microcirculation dysfunction
change in Syndecan-1 serum concentration	1st, 2nd and 3rd day	Syndecan-1 is a marker of endothelial glycocalyx

Secondary Outcome Measures

Name	Time	Method
change in albuminuria	1st, 2nd and 3rd day	albuminuria is a marker of glomerular endothelial cells dysfunction
mortality in 28 days	30 days	mortality in 28 days from ICU admission

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Třebeš, Czechia