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Completed

NCT Number: NCT03960307

Glycocalyx and Microcirculation in Sepsis

The aim of this observative, prospective study with cross-sectional design is to explore possible correlations/associations between microcirculation parameters and sublingual endothelial glycocalyx in sepsis. Therefore, 30 critically ill septic patients and 10 healthy controls were enrolled.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitiy Hospital Muenster

Münster, 48149, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

- septic ICU cohort:

  • Sepsis (based on sepsis-3 criteria)
  • ICU stay

Inclusion criteria

- healthy controls:

  • Adult healthy individuals

Exclusion criteria

(for all groups):

  • Underage
  • pregnancy
  • oral mucosal inflammation or injury

Treatment and study plan

Microcirculation and Glycocalyx assessment

Other

Non-invasive assessment of endothelial glycocalyx dimensions (PBR) and microcirculatory parameters (e.g. PPV, PVD, TVD, MFI)

Primary outcomes

  1. Correlations between Perfused Boundary Region (PBR) and Microvascular Flow Index (MFI) measured sublingually

    Time frame: During ICU stay, an average of 2 days after sepsis onset

    Glycocalyx thickness will be measured with PBR (in μm) and MFI will be assessed in points. Possible correlations at a given timepoint will be explored (e.g. Spearman's Correlation).

  2. Correlations between Perfused Boundary Region (PBR) and Proportion of Perfused Vessels (PPV) measured sublingually

    Time frame: During ICU stay, an average of 2 days after sepsis onset

    Glycocalyx thickness will be measured with PBR (in μm) and PPV will be assessed in percentage. Possible correlations at a given timepoint will be explored (e.g. Spearman's Correlation).

  3. Correlations between Perfused Boundary Region (PBR) and Perfused Vessel Density (PVD) measured sublingually

    Time frame: During ICU stay, an average of 2 days after sepsis onset

    Glycocalyx thickness will be measured with PBR (in μm) and PVD will be assessed in mm/mm^2. Possible correlations at a given timepoint will be explored (e.g. Spearman's Correlation).

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

Association of Sublingual Microcirculation Parameters and Endothelial Glycocalyx Dimensions in Resuscitated Sepsis: A Cross-sectional Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 23, 2019
Registry last updated
Sep 8, 2023

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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