Evaluation of Lipid Emulsion on GCX in Critically Ill Patients

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Device: Sublingual microcirculation assessment

• Registration Number: NCT03216850
• Lead Sponsor: University Hospital Hradec Kralove

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),

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Study Start: 2018-01-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-12-31
• Results First Submitted: 2019-03-25
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-08
• Last Update Submitted: 2019-11-08
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in ICU requiring parenteral nutrition	Sublingual microcirculation assessment	-

Primary Outcome Measures

Name	Time	Method
Endothelial Glycocalyx Thickness	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.

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Třebeš, Czechia