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

• Sponsor: University Hospital Hradec Kralove (Other)
• Overall Status: Completed
• CT.gov ID: NCT04644302
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Viral Pneumonia; Sepsis	Diagnostic Test: microcirculation recording

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 Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Jul 1, 2021
• Actual Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
non-COVID sepsis Patients admitted to ICU with sepsis of non-COVID origin	Diagnostic Test: microcirculation recording; non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws; Other Names: biochemical markeres investigation
COVID sepsis Patients admitted to ICU with sepsis of COVID origin	Diagnostic Test: microcirculation recording; non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws; Other Names: biochemical markeres investigation

Outcome Measures

Primary Outcome Measures

1. change in Proportion of Perfused Vessels (PPV) parameter [1st, 2nd and 3rd day]

   PPV describes microcirculation dysfunction

2. change in Syndecan-1 serum concentration [1st, 2nd and 3rd day]

   Syndecan-1 is a marker of endothelial glycocalyx

Secondary Outcome Measures

1. change in albuminuria [1st, 2nd and 3rd day]

   albuminuria is a marker of glomerular endothelial cells dysfunction

2. mortality in 28 days [30 days]

   mortality in 28 days from ICU admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Králové	Třebeš	Czechia	50005

Sponsors and Collaborators

• University Hospital Hradec Kralove

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vladimir Cerny, professor, University Hospital Hradec Kralove
• ClinicalTrials.gov Identifier: NCT04644302
• Other Study ID Numbers: FNHK_IGS_8144
• First Posted: Nov 25, 2020
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vladimir Cerny, professor, University Hospital Hradec Kralove: microcirculation; endothelial glycocalyx; COVID-19
• Additional relevant MeSH terms: COVID-19; Sepsis; Toxemia; Pneumonia, Viral

Study Results

No Results Posted as of Sep 30, 2021