Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX
Conditions: Endothelial Dysfunction
Sponsor: University Hospital Hradec Kralove

COVER PAGE 
 
Official title: Evaluation of lipid emulsion on GCX in critically ill patients. 
 
NTC number: NCT03216850 
 
Date of the document: 7. 11. 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objective: To assess the influence of lipid emulsion on EG integrity in ICU patients using 
video microscopic and biochemical methods.  
Design: Prospective observational single centre study. 
Methods: Patients in surgical ICU after major abdominal surgery or cardio surgery and in 
general ICU were assessed for eligibility for this pilot observational study in University 
Hospital. The study was performed during the first day of adding lipids as a part of their PN. 
The patients were given the SMOFlipid 20% for 6 hours in prescribed dose of approx. 1g/kg 
of body weight.  EG integrity was measured indirectly by automated sublingual video 
microscopy calculating a parameter PBR which describes the amount of lateral deviation of 
red blood cells from the central column and by levels of syndecan-1 and syndecan-4 in 
plasma as EG degradational products. Measurements were performed before lipid 
administration (T0) and 30 minutes after (T6) the infusion of lipid emulsion was completed. 
Scientific background: Endothelial glycocalyx (EG) is a carbohydrate-rich vascular lining of 
the apical surface of endothelial cells. It has been proved to have an essential role in vascular 
homeostasis. Lipid emulsions as part of parenteral nutrition (PN) are widely used in patients in 
the setting of critical care and perioperative medicine. Due to their structure, lipids may 
potentially interact with EG. The aim of the study was to evaluate the effect of lipid emulsion 
on EG.  
Statistical considerations: The study was designed as a pilot prospective observational and 
feasibility study because there were no existing data regarding the methodical approach to 
glycocalyx assessment after exposure to lipid emulsion in clinical settings. We planned to 
enrol in the pilot study 15 patients, such sample size was deemed to be sufficient to obtain 
pilot data for hypothesis verification. Results were summarized using descriptive statistics and 
presented as mean (SD) for continuous variables, and as median (IQR) for non-normally 
distributed data. Shapiro-Wilk test was used for normality tests, Student´s paired t-tests were 
used to test the difference between parameters obtained at T0 and T6 time points. Pearson 
correlation and Spearman rank order correlation analysis were performed to test the 
relationship between PBR values and soluble fraction of syndecans-1 and syndecan-4. The 
level of significance was set at p < 0.05. MedCalc 7.6.0. (MedCalc Software, Ostend, 
Belgium) and Prism 5 for Mac OS X (Version 5. Ob, December 19, 2008) was used for 
statistical analysis. 
 
 
 
 
 
 
Chief Investigator: Vladimir Cerny  

Sponsor Number: AZVCR 15-3881/A, all rights reserved. 
Name of site: Hradec Kralove