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

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

U.S. FDA Resources

Groups and Cohorts

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

Primary Outcome Measures :

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).

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rovas A, Seidel LM, Vink H, Pohlkötter T, Pavenstädt H, Ertmer C, Hessler M, Kümpers P. Association of sublingual microcirculation parameters and endothelial glycocalyx dimensions in resuscitated sepsis. Crit Care. 2019 Jul 24;23(1):260. doi: 10.1186/s13054-019-2542-2.

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Responsible Party:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT03960307 History of Changes
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

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