Glycocalyx Damage in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146585
• Other study ID #: AZVCR 9307_3
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2020
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients admitted to ICU

• artifitial ventilation

• renal replacement therapy

• targeted temperatura management

Exclusion Criteria:

• pregnant women

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• PBR assessment
Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Králové	Trebeš

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfused Boundary Region (PBR) in One Week	PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.	One week on ICU