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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in ICU requiring parenteral nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual microcirculation assessment | Device | Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who meet the inclusion criteria admitted to the ICU.
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Cerny, MD | University Hospital Hradec Kralove | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Kralove | Hradec Králové | Třebeš | 50005 | Czechia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients in ICU Requiring Parenteral Nutrition | Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients in ICU Requiring Parenteral Nutrition | Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | micrometer | One week within the ICU care |
|
|
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Measurement of the endothelial glycocalyx thickness is harmless and partially non-invasive. The study was observational and did not aim at collecting the data about adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients in ICU Requiring Parenteral Nutrition | Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Astapenko | University Hospital Hradec Kralove | +420495833218 | astapenko.d@seznam.cz |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2019 | Nov 8, 2019 | Prot_SAP_000.pdf |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| PBR value | Perfused Boundary Region (PBR) is an indirect assessment of the endothelial glycocalyx thickness in sublingual microcirculation. | Median | Inter-Quartile Range | micrometer |
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