To Develop an Algorithm for Predicting the Unfavorable Course of Sepsis in Children Based on a Comprehensive Assessment of Immunological, Biochemical and Molecular Genetic Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
研究概览
简要总结
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.
详细描述
- analyze biochemical markers and immune status data in sepsis patients and in the comparison group;
- assess the state of the cellular immunity, level of pro-inflammatory cytokines, genetic polymorphism of immune response genes in sepsis patients;
- carry out a correlation analysis of clinical and laboratory data and immune system among patients of different groups (with and without septic shock, taking into account the outcome);
- assess the relationship between the genetic characteristics of the patient's immune system and the severity of the pathological process;
- based on the data obtained, prepare instructions for use, which describes an algorithm to predict the unfavorable course of sepsis in children.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- age from 1 month to 18 years;
- confirmed septic process$
- informed consent.
排除标准
- age from 18 years;
- refuse of patient to participate in the trial;
- chronic mental disorders with severe manifestations;
- pregnancy/lactation;
- intercurrent severe chronic diseases;
- HIV, Hepatites B/C;
- active tuberculosis;
- cachexia of any origin;
- malignant neoplasms.
方案终点
主要结局
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
时间窗: 1 month
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.
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
时间窗: 1 month
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.
次要结局
未报告次要终点
试验结果
结果已于 2025-12-30 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看
受试者流程
入组 185 人 · 完成 185 人
主要终点
Blood Leukocyte Subpopulations: the Absolute Numbers of Leukocytes of Specific Phenotypes
10^9 cells/l · Inter-Quartile Range · 时间窗: 1 month
| 分类 | Patients With Sepsis, Day 1 （n=50） | Patients With Sepsis, Day 7 （n=47） | Patients With Severe Bacterial Infection （n=33） | Patients With Severe Viral Infection （n=20） | Control Group （n=35） |
|---|---|---|---|---|---|
| WBC, 10^9 cells/l | 16.0 (8.7–19.8) | 11.2 (7.7–18.6) | 11.9 (8.7–14.3) | 4.9 (3.8–7.1) | 6.9 (6.0–8.8) |
| lymphocyte, 10^9 cells/l | 1.83 (1.23–3.01) | 3.10 (1.84–4.19) | 1.93 (0.97–3.02) | 1.14 (0.79–1.65) | 3.24 (2.44–3.89) |
| T-lymphocytes,10^9 cells/l | 1.28 (0.65–2.20) | 2.0 (1.2–2.9) | 1.24 (0.59–2.32) | 0.81 (0.44–1.28) | 2.1 (1.64–2.62) |
| NK-cells,10^9 cells/l | 0.10 (0.05–0.19) | 0.14 (0.08–0.35) | 0.10 (0.06–0.22) | 0.15 (0.09–0.21) | 0.36 (0.23–0.50) |
| NKT-cells,10^9 cells/l | 0.020 (0.012–0.044) | 0.050 (0.026–0.11) | 0.025 (0.012–0.041) | 0.038 (0.022–0.071) | 0.083 (0.041–0.16) |
| T-helpers,10^9 cells/l | 0.65 (0.34–1.43) | 1.0 (0.61–1.78) | 0.73 (0.37–1.68) | 0.40 (0.28–0.80) | 1.19 (0.89–1.34) |
| T-cytotoxic,10^9 cells/l | 0.40 (0.21–0.71) | 0.69 (0.43–1.1) | 0.39 (0.18–0.66) | 0.30 (0.15–0.40) | 0.74 (0.55–0.85) |
| B-lymphocytes,10^9 cells/l | 0.36 (0.17–0.78) | 0.54 (0.19–0.80) | 0.58 (0.30–1.0) | 0.16 (0.11–0.26) | 0.43 (0.24–0.66) |
| monocytes,10^9 cells/l | 1.04 (0.35–1.55) | 0.78 (0.34–1.19) | 0.87 (0.55–1.50) | 0.4 (0.24–0.62) | 0.46 (0.35–0.50) |
| сlassical monocytes,10^9 cells/l | 0.66 (0.27–1.28) | 0.45 (0.14–0.93) | 0.76 (0.45–1.26) | 0.28 (0.19–0.51) | 0.38 (0.28–0.42) |
| Intermediate monocytes,10^9 cells/l | 0.09 (0.025–0.20) | 0.04 (0.01–0.09) | 0.06 (0.03–0.13) | 0.05 (0.03–0.09) | 0.027 (0.018–0.043) |
| nonclassical monocytes,10^9 cells/l | 0.014 (0.0022–0.038) | 0.008 (0.001–0.027) | 0.015 (0.0046–0.048) | 0.011 (0.007–0.021) | 0.004 (0.003–0.017) |
p = <0.05 · Wilcoxon (Mann-Whitney)
Blood Leukocyte Subpopulations: Flow Cytometry Measure (Percentage of Cells of Parent Population, %)
percentage of cells of parent population · Inter-Quartile Range · 时间窗: 1 month
| 分类 | Patients With Sepsis, Day 1 （n=50） | Patients With Sepsis, Day 7 （n=47） | Patients With Severe Bacterial Infection （n=33） | Patients With Severe Viral Infection （n=20） | Control Group （n=35） |
|---|---|---|---|---|---|
| % leukocytes that are lymphocytes | 15.2 (9.9–25.6) | 30.3 (18.3–39.9) | 15.7 (11.1–18.9) | 24.9 (13.6–36.1) | 44.5 (35.4–52.0) |
| % lymphocytes that are T-cells | 67.4 (59.1–77.6) | 71.5 (65.2–76.0) | 62.9 (57.5–67.9) | 69.3 (65.5–74.7) | 71.5 (62.9–76.9) |
| % lymphocytes that are NK-cells | 5.42 (3.01–10.98) | 7.4 (4.3–10.2) | 4.5 (3.2–10.7) | 13.35 (8.79–18.32) | 11.6 (8.0–17.1) |
| % T-lymphocytes that are NKT-cells | 1.19 (0.6–2.3) | 2.2 (1.0–3.5) | 1.13 (0.7–2.1) | 3.4 (1.85–5.45) | 3.4 (1.5–4.2) |
| % T-lymphocytes that are T-helpers | 37.6 (26.6–48.9) | 41.4 (36.4–47.9) | 36.8 (33.6–44.2) | 39.8 (31.66–47.38) | 34.8 (29.1–41.0) |
| % T-lymphocytes that are T-cytotoxic cells | 20.1 (16.0–28.8) | 24.8 (18.9–29.8) | 19.1 (15.2–23.4) | 22.46 (18.89–26.43) | 22.9 (20.1–27.7) |
| % lymphocytes that are B-cells | 20.5 (13.6–31.6) | 17.3 (10.7–23.2) | 27.4 (21.3–33.0) | 14.18 (10.96–17.03) | 13.5 (10.3–17.4) |
| % monocytes that are classical | 74.6 (67.0–81.4) | 81.2 (76.5–87.7) | 83.0 (75.7–85.7) | 78.0 (62.6–80.05) | 82.8 (78.8–88.1) |
| % monocytes that are intermediate | 11.4 (7.17–18.5) | 7.02 (3.42–9.7) | 6.28 (4.93–12.4) | 12.6 (7.83–19.65) | 6.1 (4.2–9.5) |
| % monocytes that are nonclassical | 2.03 (1.08–3.89) | 1.15 (0.56–2.43) | 2.16 (1.05–3.67) | 3.5 (1.39–5.3) | 1.1 (0.5–3.4) |
| % neutrophils that express CD64 | 83.9 (74.0–93.7) | 5.55 (1.25–33.9) | 81.4 (44.7–94.3) | 0.35 (0.2–16.33) | 0.7 (0.3–1.6) |
| % monocytes that express HLA-DR | 58.98 (28.76–96.64) | 88.54 (53.36–93.5) | 62.63 (44.07–95.6) | 86.4 (56.2–98.9) | 67.0 (56.3–97.1) |
p = <0.05 · Wilcoxon (Mann-Whitney)
p = <0.05 · Wilcoxon (Mann-Whitney)
p = <0.02 · Wilcoxon (Mann-Whitney)
安全性
| 组别 | 严重不良事件 | 死亡 |
|---|---|---|
| Patients With Sepsis on Day 1 | 3 / 50 | 3 / 50 |
| Patients With Sepsis on Day 7 | 0 / 47 | 0 / 47 |
| Patients With Severe Bacterial Infection | 0 / 33 | 0 / 33 |
| Patients With Severe Viral Infection | 0 / 20 | 0 / 20 |
| Control Group | 0 / 35 | 0 / 35 |
最常见的严重不良事件（人数）
| 事件 | Patients With Sepsis on Day 1 | Patients With Sepsis on Day 7 | Patients With Severe Bacterial Infection | Patients With Severe Viral Infection | Control Group |
|---|---|---|---|---|---|
| death | 3 / 50 | 0 / 47 | 0 / 33 | 0 / 20 | 0 / 35 |
数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。
研究者
E.G.Fomina
Head of the Laboratory for Immunology and Cellular Biotechnology
The Republican Research and Practical Center for Epidemiology and Microbiology
研究点 (1)
标识符
- NCT 编号
- NCT05908162
- 其他研究编号
- NCT06142162, RRPCEM_SEPSIS
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- 最近更新
- (9个月前)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 是