Circulatory Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis
Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study
1 other identifier
observational
28
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedSeptember 30, 2021
September 1, 2021
1.4 years
November 24, 2020
September 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change in Proportion of Perfused Vessels (PPV) parameter
PPV describes microcirculation dysfunction
1st, 2nd and 3rd day
change in Syndecan-1 serum concentration
Syndecan-1 is a marker of endothelial glycocalyx
1st, 2nd and 3rd day
Secondary Outcomes (2)
change in albuminuria
1st, 2nd and 3rd day
mortality in 28 days
30 days
Study Arms (2)
non-COVID sepsis
Patients admitted to ICU with sepsis of non-COVID origin
COVID sepsis
Patients admitted to ICU with sepsis of COVID origin
Interventions
non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws
Eligibility Criteria
Adult patients admitted to the ICU with signs of circulatory instability with any method of organ support. Patients expected to have a particular method of organ support for at least 3 days.
You may qualify if:
- 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
You may not qualify if:
- family withdrawal/disagreement
- death within three days from ICU admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hradec Kralove
Hradec Králové, Třebeš, 50005, Czechia
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 24, 2020
First Posted
November 25, 2020
Study Start
February 1, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
September 30, 2021
Record last verified: 2021-09