Sepsis Clinical Trial
Official title:
Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study
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 |
Verified date | September 2021 |
Source | University Hospital Hradec Kralove |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Hradec Kralove | Hradec Králové | Trebeš |
Lead Sponsor | Collaborator |
---|---|
University Hospital Hradec Kralove |
Czechia,
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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