Endothelial Dysfunction
Conditions
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),
Interventions
Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
Sponsors
University Hospital Hradec Kralove
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients in ICU Requiring Parenteral Nutrition Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Pre-analytical error | 6 |
Baseline characteristics
| Characteristic | Patients in ICU Requiring Parenteral Nutrition | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 15 Participants | — |
| Age, Continuous | 64 years STANDARD_DEVIATION 12 | — |
| PBR value | 2.10 micrometer | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Czechia | 15 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: One week within the ICU care
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients in ICU Requiring Parenteral Nutrition | Endothelial Glycocalyx Thickness | 2.28 micrometer |