Glycocalyx and Microcirculation in Sepsis

September 7, 2023 updated by: University Hospital Muenster

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, 48149
        • Universitiy Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During ICU stay, an average of 2 days after sepsis onset
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).
During ICU stay, an average of 2 days after sepsis onset
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).
During ICU stay, an average of 2 days after sepsis onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Philipp Kümpers, MD, University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDF_SDF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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