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OpenTrials
Completed

NCT Number: NCT03146585

Glycocalyx Damage in Critically Ill Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hradec Kralove

Hradec Králové, Třebeš, 50005, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnant women

Treatment and study plan

PBR assessment

Device

Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 10, 2017
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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