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

September 29, 2021 updated by: Vladimir Cerny, University Hospital Hradec Kralove

Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Třebeš
      • Hradec Králové, Třebeš, Czechia, 50005
        • University Hospital Hradec Kralove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2020

Primary Completion (ACTUAL)

July 1, 2021

Study Completion (ACTUAL)

July 1, 2021

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (ACTUAL)

November 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNHK_IGS_8144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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