Evaluation of Lipid Emulsion on GCX in Critically Ill Patients
Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX
1 other identifier
observational
15
1 country
1
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),
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
November 27, 2019
CompletedNovember 27, 2019
November 1, 2019
8 months
July 11, 2017
March 25, 2019
November 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Patients in ICU requiring parenteral nutrition
Interventions
Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
Eligibility Criteria
All patients who meet the inclusion criteria admitted to the ICU.
You may qualify if:
- patients in ICU
- indication for lipid administration as a part of TPN
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hradec Kralove
Hradec Králové, Třebeš, 50005, Czechia
Results Point of Contact
- Title
- Dr. David Astapenko
- Organization
- University Hospital Hradec Kralove
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir Cerny, MD
University Hospital Hradec Kralove
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 13, 2017
Study Start
January 1, 2018
Primary Completion
August 31, 2018
Study Completion
December 31, 2018
Last Updated
November 27, 2019
Results First Posted
November 27, 2019
Record last verified: 2019-11