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Glycocalyx and Microcirculation in Sepsis

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ClinicalTrials.gov Identifier: NCT03960307
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Sepsis Other: Microcirculation and Glycocalyx assessment

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Sublingual Microcirculation Parameters and Endothelial Glycocalyx Dimensions in Resuscitated Sepsis: A Cross-sectional Study
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Septic patients
ICU patients with resuscitated sepsis, based on the sepsis-3 criteria. (n=30)
 Other: Microcirculation and Glycocalyx assessment
Non-invasive assessment of endothelial glycocalyx dimensions (PBR) and microcirculatory parameters (e.g. PPV, PVD, TVD, MFI)
Healthy controls
Apparently healthy controls (n=10)
 Other: Microcirculation and Glycocalyx assessment
Non-invasive assessment of endothelial glycocalyx dimensions (PBR) and microcirculatory parameters (e.g. PPV, PVD, TVD, MFI)


Outcome Measures
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Primary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.
  • Healthy Controls
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960307


Locations
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Germany
Universitiy Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Philipp Kümpers, MD University Hospital Muenster
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT03960307    
Other Study ID Numbers: IDF_SDF
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
Glycocalyx
PBR
microcirculation
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes