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Clinical Trials/NCT03216850
NCT03216850
Completed
Not Applicable

Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX

University Hospital Hradec Kralove1 site in 1 country15 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endothelial Dysfunction
Sponsor
University Hospital Hradec Kralove
Enrollment
15
Locations
1
Primary Endpoint
Endothelial Glycocalyx Thickness
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx.

The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled.

Monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vladimir Cerny

Clinical Professor

University Hospital Hradec Kralove

Eligibility Criteria

Inclusion Criteria

  • patients in ICU
  • indication for lipid administration as a part of TPN

Exclusion Criteria

  • shock or clinical/laboratory signs of tissue hypoperfusion
  • previous lipid infusions (within 3 months before entering study)
  • hyperlipidaemia
  • hyperglycaemia (over 10 mmol/l)
  • current or previous (within 72 hours before entering the study) use of propofol
  • pancreatitis
  • severe liver failure
  • current use of statins

Outcomes

Primary Outcomes

Endothelial Glycocalyx Thickness

Time Frame: One week within the ICU care

Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.

Study Sites (1)

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