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Completed

NCT Number: NCT04644302

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

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

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Key information

Conditions

Viral Pneumonia COVID-19 Coronaviridae Infections Coronavirus Infections Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hradec Kralove

Hradec Králové, Třebeš, 50005, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microcirculation recording

Diagnostic Test

non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws

Other names: biochemical markeres investigation

Primary outcomes

  1. change in Proportion of Perfused Vessels (PPV) parameter

    Time frame: 1st, 2nd and 3rd day

    PPV describes microcirculation dysfunction

  2. change in Syndecan-1 serum concentration

    Time frame: 1st, 2nd and 3rd day

    Syndecan-1 is a marker of endothelial glycocalyx

Secondary outcomes

  1. change in albuminuria

    Time frame: 1st, 2nd and 3rd day

    albuminuria is a marker of glomerular endothelial cells dysfunction

  2. mortality in 28 days

    Time frame: 30 days

    mortality in 28 days from ICU admission

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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