Evaluation of Lipid Emulsion on GCX in Critically Ill Patients

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),

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Key information

Conditions

Endothelial Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Hradec Kralove

Hradec Králové, Třebeš, 50005, Czechia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublingual microcirculation assessment

Device

Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.

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.

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jul 13, 2017
Registry last updated: Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed