Critical Illness
Conditions
Keywords
Glycocalyx
Brief summary
The hypothesis to be tested: GCX damage and its dynamics correlate to various patient related factors and to using organ-supporting measures. There is a correlation between length of organ support and GCX damage. The aim of the study: Evaluation of the relationship between GCX damage and duration of various organ supporting measures. Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring organ supporting therapy. Sample size: We plan enrollment of 75 patients on invasive ventilatory support in the duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and 20 patients with target temperature management for neuroprotection. Intervention: none Data to be recorded and analysed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7 and/or at discharge or before death, microcirculatory data, and Perfused Boundary Region.
Interventions
DEVICEPBR assessment
Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
Sponsors
University Hospital Hradec Kralove
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients admitted to ICU * artifitial ventilation * renal replacement therapy * targeted temperatura management
Exclusion criteria
* pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perfused Boundary Region (PBR) in One Week | One week on ICU | PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation. |
Countries
Czechia
Participant flow
Recruitment details
Adult patients admitted to our ICU with any kind of organ support.
Participants by arm
| Arm | Count |
|---|---|
| Patients on Artificial Ventilation PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. | 25 |
| Patients on Renal Replacement Therapy PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. | 10 |
| Patients With Targeted Temperature Management PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. | 5 |
| Total | 40 |
Baseline characteristics
| Characteristic | Patients on Artificial Ventilation | Patients on Renal Replacement Therapy | Patients With Targeted Temperature Management | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 10 Participants | 5 Participants | 40 Participants |
| Age, Continuous | 45 years STANDARD_DEVIATION 5 | 50 years STANDARD_DEVIATION 6 | 62 years STANDARD_DEVIATION 3 | 60 years STANDARD_DEVIATION 5 |
| PBR value | 2.02 micrometer | 2.13 micrometer | 2.07 micrometer | 2.10 micrometer |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Czechia | 25 Participants | 10 Participants | 5 Participants | 40 Participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 3 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Perfused Boundary Region (PBR) in One Week
PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.
Time frame: One week on ICU
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients on Artificial Ventilation | Perfused Boundary Region (PBR) in One Week | 1.95 micrometer |
| Patients on Renal Replacement Therapy | Perfused Boundary Region (PBR) in One Week | 1.97 micrometer |
| Patients With Targeted Temperature Management | Perfused Boundary Region (PBR) in One Week | 2.02 micrometer |