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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on artificial ventilation |
| ||
| Patients on renal replacement therapy |
| ||
| Patients with targeted temperature management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBR assessment | Device | Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perfused Boundary Region (PBR) in One Week | PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation. | One week on ICU |
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Inclusion Criteria:
Exclusion Criteria:
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All patients admitted to ICU meeting inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Cerny, MD, PhD, FCCM | 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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Adult patients admitted to our ICU with any kind of organ support.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients on Artificial Ventilation | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
| FG001 | Patients on Renal Replacement Therapy | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
| FG002 | Patients With Targeted Temperature Management | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients on Artificial Ventilation | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
| BG001 | Patients on Renal Replacement Therapy |
| 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 | Perfused Boundary Region (PBR) in One Week | PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation. | Posted | Median | Inter-Quartile Range | micrometer | One week on ICU |
|
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Adverse events were not collected since the study is observational. If the patient died it was due to the natural course of the disease.
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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 on Artificial Ventilation | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Astapenko | University Hospital Hradec Kralove | +420608177374 | 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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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
| BG002 | Patients With Targeted Temperature Management | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PBR value | The Perfused Boundary Region (PBR) is an indirect assessment of the thickness of the endothelial glycocalyx in sublingual microcirculation. | Mean | Inter-Quartile Range | micrometer |
|
| Patients With Targeted Temperature Management |
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Patients on Renal Replacement Therapy | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Patients With Targeted Temperature Management | PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|