Glycocalyx and Microcirculation in Sepsis

NCT03960307 | Completed

• 1 other identifier: IDF_SDF
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Glycocalyx; PBR; microcirculation

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  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

Study Arms (2)

Septic patients

ICU patients with resuscitated sepsis, based on the sepsis-3 criteria. (n=30)

Other: Microcirculation and Glycocalyx assessment

Healthy controls

Apparently healthy controls (n=10)

Other: Microcirculation and Glycocalyx assessment

Interventions

Microcirculation and Glycocalyx assessment OTHER

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

Healthy controls; Septic patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Sepsis (based on sepsis-3 criteria)
• ICU stay
• \- Adult healthy individuals

You may not qualify if:

• Underage
• pregnancy
• oral mucosal inflammation or injury

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Universitiy Hospital Muenster

Münster, 48149, Germany

Location

Related Publications (1)

• Rovas A, Seidel LM, Vink H, Pohlkotter T, Pavenstadt H, Ertmer C, Hessler M, Kumpers 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.

  PMID: 31340868 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Microcirculation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Philipp Kümpers, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 23, 2019
• Study Start: July 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: September 8, 2023

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)