Glycocalyx Damage in Critically Ill Patients

Completed

• Conditions: Critical Illness
• Interventions: Device: PBR assessment

• Registration Number: NCT03146585
• Lead Sponsor: University Hospital Hradec Kralove

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-07
• Study First Posted: 2017-05-10
• Primary Completion: 2017-12-31
• Study Completion: 2018-06-30
• Results First Submitted: 2019-03-25
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Results First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients on renal replacement therapy	PBR assessment	-
Patients with targeted temperature management	PBR assessment	-
Patients on artificial ventilation	PBR assessment	-

Primary Outcome Measures

Name	Time	Method
Perfused Boundary Region (PBR) in One Week	One week on ICU	PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Třebeš, Czechia