Glycocalyx Damage in Critically Ill Patients

March 27, 2020 updated by: Vladimir Cerny, University Hospital Hradec Kralove

Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection

The hypothesis to be tested: GCX damage and its dynamics correlate to various patient related factors and to using organ-supporting measures. There is a correlation between length of organ support and GCX damage.

The aim of the study: Evaluation of the relationship between GCX damage and duration of various organ supporting measures.

Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring organ supporting therapy.

Sample size: We plan enrollment of 75 patients on invasive ventilatory support in the duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and 20 patients with target temperature management for neuroprotection.

Intervention: none Data to be recorded and analysed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7 and/or at discharge or before death, microcirculatory data, and Perfused Boundary Region.

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

  • Czechia
    • Třebeš
      • Hradec Králové, Třebeš, Czechia, 50005
        • University Hospital Hradec Kralove

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to ICU meeting inclusion criteria.

Description

Inclusion Criteria:

  • adult patients admitted to ICU
  • artifitial ventilation
  • renal replacement therapy
  • targeted temperatura management

Exclusion Criteria:

  • pregnant women

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients on artificial ventilation
Device: PBR assessment
Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
Patients on renal replacement therapy
Device: PBR assessment
Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
Patients with targeted temperature management
Device: PBR assessment
Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfused Boundary Region (PBR) in One Week
Time Frame: One week on ICU
PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.
One week on ICU

Collaborators and Investigators

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

Sponsor

University Hospital Hradec Kralove

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)

November 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

May 7, 2017

First Submitted That Met QC Criteria

May 7, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZVCR 9307_3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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