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

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

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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 |
- Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.
- Healthy Controls
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

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
Germany | |
Universitiy Hospital Muenster | |
Muenster, Germany, 48149 |
Principal Investigator: | Philipp Kümpers, MD | University Hospital Muenster |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glycocalyx PBR microcirculation |
Sepsis Toxemia Infections |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |