- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216850
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
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),
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Třebeš
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Hradec Králové, Třebeš, Czechia, 50005
- University hospital Hradec Králové
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients in ICU requiring parenteral nutrition
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Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One week within the ICU care
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Collaborators and Investigators
Investigators
- Principal Investigator: Vladimir Cerny, MD, University hospital Hradec Králové
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AZVCR 9307_5/a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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