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| Name | Class |
|---|---|
| Belarusian State Medical University | OTHER |
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A comprehensive strategy will be used to investigate the relationship and correlation between 4 diagnostically significant markers relevant for early diagnosis and prediction of complications and death in the development of sepsis in children (C-reactive protein, procalcitonin, presepsin and lipopolysaccharide binding protein). For the first time, an attempt will be made to assess the genetic characteristics of the patient's from the point of view of predisposition to the unfavorable development of the sepsis based on the study of polymorphism of a number of genes of the immune system (tumor necrosis factor beta; interleukin 6, 8, 10; lymphotoxin alpha, etc.).
Based on the study results, an algorithm to predict the unfavorable course of sepsis in children will be developed using a comprehensive assessment of biochemical and molecular genetic markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with sepsis on day 1 | Patients with sepsis on day 1 |
| |
| Patients with sepsis on day 7 | Patients with sepsis on day 7 |
| |
| Patients with severe bacterial infection | Patients with severe bacterial infection (pneumonia) |
| |
| Patients with severe viral infection | Patients with severe viral infection (COVID19) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bood leukocyte subsets | Diagnostic Test | Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes | Determination of blood leukocyte subpopulations and their total number in the blood samples (10^9 cells/l): WBC (leukocytes), CD45+(lymphocytes),CD3+ (T-lymphocytes), CD3- CD16/56+ (NK-cells), CD3+ CD16/56+ (NKT-cells), CD3+ CD4+ (T-helpers), CD3+ CD8+ (T-cytotoxic cells), CD19+ (B-lymphocytes), CD14+ (monocytes): CD14+CD16- (сlassical monocytes), CD14+СD16+(Intermediate monocytes), СD14-СD16+(nonclassical monocytes). Leucocyte count was determined under a microscope in a Goryaev chamber. | 1 month |
| Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %) | Determination of the relative subpopulations of blood leukocytes (percentage of cells of parent population, %): CD45+ (% leukocytes that are lymphocytes), CD3+ (% lymphocytes that are T-cells), CD3- CD16/56+ (% lymphocytes that are NK-cells), CD3+ CD16/56+ (% T-lymphocytes that are NKT-cells), CD3+ CD4+ (% T-lymphocytes that are T-helpers), CD3+ CD8+ (% T-lymphocytes that are T-cytotoxic cells), CD19+ (% lymphocytes that are B-cells), CD14+ CD16- (% monocytes that are classical), CD14+ CD16+ (% monocytes that are intermediate), CD14- CD16+ (% monocytes that are nonclassical), nCD64+ (% neutrophils that express CD64), mHLA-DR (% monocytes that express human leukocyte antigen-DR (HLA-DR)). Cell samples were counted on a FACSCalibur cytofluorimeter. Data were analyzed using Flowing Software version 2.5.1 or BD FACSDiva 7.0. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe viral infection, with sepsis on day 1 and day 7
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| Name | Affiliation | Role |
|---|---|---|
| Elena G Fomina, Dr | The Republican Research and Practical Center for Epidemiology and Microbiology (RRPCEM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Children's Infectious Clinical Hospital | Minsk | Belarus |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Sepsis on Day 1 | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| FG001 | Patients With Sepsis on Day 7 | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| FG002 | Patients With Severe Bacterial Infection | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| FG003 | Patients With Severe Viral Infection | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| FG004 | Control Group | Group of healthy patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Sepsis on Day 1 | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| BG001 | Patients With Sepsis on Day 7 |
| 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 | Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes | Determination of blood leukocyte subpopulations and their total number in the blood samples (10^9 cells/l): WBC (leukocytes), CD45+(lymphocytes),CD3+ (T-lymphocytes), CD3- CD16/56+ (NK-cells), CD3+ CD16/56+ (NKT-cells), CD3+ CD4+ (T-helpers), CD3+ CD8+ (T-cytotoxic cells), CD19+ (B-lymphocytes), CD14+ (monocytes): CD14+CD16- (сlassical monocytes), CD14+СD16+(Intermediate monocytes), СD14-СD16+(nonclassical monocytes). Leucocyte count was determined under a microscope in a Goryaev chamber. | Posted | Mean | Inter-Quartile Range | 10^9 cells/l | 1 month |
|
3 years
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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 With Sepsis on Day 1 | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of laboratory Fomina E.G. | Republican center of Hygiene, Epidemiology and Public Health | +375173740417 | feg1@tut.by |
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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 | Jun 6, 2024 | Jan 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Peripheral blood, serum
|
Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils
| BG002 | Patients With Severe Bacterial Infection | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| BG003 | Patients With Severe Viral Infection | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| BG004 | Control Group | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| 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 | Number | participants |
|
Patients with sepsis on day 7 |
| OG002 | Patients With Severe Bacterial Infection | Patients with severe bacterial infection (pneumonia) |
| OG003 | Patients With Severe Viral Infection | Patients with severe viral infection (COVID19) |
| OG004 | Control Group | Group of healthy patients |
|
|
|
| Primary | Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %) | Determination of the relative subpopulations of blood leukocytes (percentage of cells of parent population, %): CD45+ (% leukocytes that are lymphocytes), CD3+ (% lymphocytes that are T-cells), CD3- CD16/56+ (% lymphocytes that are NK-cells), CD3+ CD16/56+ (% T-lymphocytes that are NKT-cells), CD3+ CD4+ (% T-lymphocytes that are T-helpers), CD3+ CD8+ (% T-lymphocytes that are T-cytotoxic cells), CD19+ (% lymphocytes that are B-cells), CD14+ CD16- (% monocytes that are classical), CD14+ CD16+ (% monocytes that are intermediate), CD14- CD16+ (% monocytes that are nonclassical), nCD64+ (% neutrophils that express CD64), mHLA-DR (% monocytes that express human leukocyte antigen-DR (HLA-DR)). Cell samples were counted on a FACSCalibur cytofluorimeter. Data were analyzed using Flowing Software version 2.5.1 or BD FACSDiva 7.0. | Posted | Mean | Inter-Quartile Range | percentage of cells of parent population | 1 month |
|
|
|
|
| 3 |
| 50 |
| 3 |
| 50 |
| 0 |
| 50 |
| EG001 | Patients With Sepsis on Day 7 | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils | 0 | 47 | 0 | 47 | 0 | 47 |
| EG002 | Patients With Severe Bacterial Infection | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils | 0 | 33 | 0 | 33 | 0 | 33 |
| EG003 | Patients With Severe Viral Infection | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Control Group | Bood leukocyte subsets: Determination of blood leukocyte subpopulations, subpopulation of monocytes and expression CD64 on neutrophils | 0 | 35 | 0 | 35 | 0 | 35 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| % lymphocytes that are T-cells |
|
| % lymphocytes that are NK-cells |
|
| % T-lymphocytes that are NKT-cells |
|
| % T-lymphocytes that are T-helpers |
|
| % T-lymphocytes that are T-cytotoxic cells |
|
| % lymphocytes that are B-cells |
|
| % monocytes that are classical |
|
| % monocytes that are intermediate |
|
| % monocytes that are nonclassical |
|
| % neutrophils that express CD64 |
|
| % monocytes that express HLA-DR |
|
| Other |
| Wilcoxon (Mann-Whitney) | <0.02 | Other |