Evaluation of Lipid Emulsion on GCX in Critically Ill Patients

Endothelial Dysfunction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216850
• Other study ID #: AZVCR 9307_5/a
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2019
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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),

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2018
• Est. primary completion date: August 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Device:
• Sublingual microcirculation assessment
Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Kralove	Hradec Králové	Trebeš

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Glycocalyx Thickness	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.	One week within the ICU care