Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection
Conditions: Critical Illness
Sponsor: University Hospital Hradec Kralove

COVER PAGE 
 
Official title: Severity and time course of GCX damage in critically ill patients 
NTC number: NCT03146585 
Date of the document: 7. 11. 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objective: Endothelial glycocalyx (EG) plays central role in coupling functions of 
microcirculation and tissue metabolism. EG is particularly important in critically ill patients 
when it gets damaged. The aim of study was to describe the condition of EG in critically ill 
patients by non-invasive method in dependence of severity of the illness and usage of 
methods of organ support.  
Design: monocentric, prospective observational study. 
Setting: Intensive Care Unit (ICU), University Hospital. 
Methods: Adult patients admitted to the ICU with anticipated length of stay at least 7 days 
were enrolled. Demographic and clinical data were recorded together with sublingual 
microcirculation recordings for Perfused Boundary Region (PBR) analysis.  
Scientific background: Endothelial glycocalyx (EG) is a microscopic lining of the inner 
surface of blood vessels. The results of recent research have shown a central role of EG in the 
physiological and pathophysiological processes of microcirculation and in the development of 
endothelial damage. EG mucopolysaccharide structure makes it susceptible to degradation, 
which occurs most often in the context of critically ill patients with sepsis, trauma and 
ischemia-reperfusion injury. Clinical studies on the dynamics of EG changes in intensive care 
patients are rare, and we have not found work on the impact of organ support techniques in 
available resources. The most data are from the area of extracorporeal circulation in cardio 
surgery. Given the current evidence of EG degradation in critical conditions, we hypothesized 
that there is a relationship between the degree of EG degradation and the severity of the 
clinical condition.  
Statistical considerations: The calculation of the minimum sample size of 30 patients was 
based on the assumption of a difference in Perfused Boundary Region values as an indirect 
indicator of EG damage (detailed description of the methodology below) between healthy 
volunteers and patients in critical condition. correlation coefficient 0.6), defining type I error 
= 0.05 and study strength = 0.9. The differences between groups were calculated by type of 
data, compared with an unpaired t-test, Mann Whitney's rank test, and One-Way ANOVA. 
The Pearson correlation coefficient with a 95% confidence interval was used to assess the 
correlation between PBR and APACHE II, SOFA and fluid balance. To assess the ability of 
PBRs (sensitivity and specificity) to predict septic shock or positive fluid balance, the 
Receiver Operating Characteristic (ROC) curve was calculated. Differences with P <0.05 
were considered statistically significant. Statistical analyzes and graphs were performed using 
MedCalc 7.6.0 computer programs. (MedCalc Software, Ostend, Belgium) or Prism 5 for 
Mac OS X (Version 5, Dec. 19, 2008). 
 
 
 
Chief Investigator: Vladimir Cerny  
Sponsor Number: AZVCR 15-3881/A, all rights reserved. 
Name of site: Hradec Kralove