Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death

NCT03847493 | Unknown

• 1 other identifier: ASGARD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observative, prospective study is to evaluate if and to what extent glycocalyx damage/microcirculation data at admission in the ICU as well as during ICU stay can be predictive of mortality and clinical course in patients presenting with the suspicion of sepsis/septic shock. Therefore, the enrollment of ca 100 ICU patients is planned.

Conditions

Sepsis; Septic Shock; Endothelial Dysfunction

Keywords

perfused boundary region; PBR; Sepsis; endothelial glycocalyx; ICU

Outcome Measures

Primary Outcomes (2)

• Predictive value of glycocalyx thickness regarding clinical course.

  Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm). Clinical course will be estimated with the use of e.g. Sequential Organ Failure Assessment (SOFA) score (in points).

  Hospital stay, an expected time of 4 weeks.

• Predictive value of glycocalyx thickness regarding mortality.

  Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm).

  Hospital stay, an expected time of 4 weeks.

Secondary Outcomes (1)

• Correlation of glycocalyx thickness with disease severity.

  Hospital stay, an expected time of 4 weeks.

Study Arms (2)

Patients with suspected sepsis

Patients admitted in the ICU with the clinical suspicion of infection/sepsis.

Other: Endothelial Glycocalyx

Non-sepsis Patients (control group)

Patients admitted in the ICU with other conditions apart from infection/sepsis.

Other: Endothelial Glycocalyx

Interventions

Endothelial Glycocalyx OTHER

Non-invasive assessment of endothelial glycocalyx dimensions.

Non-sepsis Patients (control group); Patients with suspected sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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.

You may qualify if:

• ICU patients admitted to the ICU with the clinican suspicion of sepsis/septic shock.

You may not qualify if:

• Underage persons, pregnant women, patients with inflammation or trauma of sublingual mucosa.

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Universitiy Hospital Muenster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

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: February 14, 2019
• First Posted: February 20, 2019
• Study Start: April 15, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-05

Locations

DE (1)