Gene Expression Objective Definition of Early Sepsis In Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- mRNA expression
研究概览
简要总结
GEODESIC is a prospective descriptive cohort investigation that will examine the generalizability of the novel host gene expression biomarkers, SeptiCyteTM LAB, SeptiCyteTM VIRUS, SeptiCyteTM BACT, and SeptiCyteTM TRIAGE (collectively 18 genes or SeptiCyteTM LVBT) and SeptiCyteTM RAPID, for differentiating children with bacterial sepsis, versus severe viral illness, versus non-infectious related systemic inflammatory response syndrome.
详细描述
Specific Aim 1. Validate the robustness of the SeptiCyteTM LVBT gene expression signatures for providing clear discrimination between critically ill children with bacterial sepsis versus severe viral illness versus infection-negative systemic inflammation (INSI) secondary to a variety of etiologies.
Approach: We will expand our previous Genotypes And Phenotypes in Pediatric SIRS and Sepsis (GAPPSS) INSI cohort to children with recent trauma, thermal burns, anoxic-ischemic reperfusion events, exposure to cardiopulmonary bypass, extracorporeal life support, or dialytic therapy, CAR-T cell therapy, and various rheumatologic diagnoses. e we will recruit children with bacterial and viral infection who demonstrate a spectrum of illness severity and organ dysfunction. This specific aim will demonstrate the generalizability of SeptiCyteTM LVBT among critically children with life-threatening infectious disease or INSI.
Specific Aim 2. Determine if SeptiCyteTM LVBT gene expression signatures trend towards resolution of previously induced or suppressed gene expression states as critical illness resolves.
Approach: We will obtain paired blood samples for SeptiCyteTM LVBT gene expression, the first around the time of intensive care unit (ICU) admission (critically ill) and the second at ICU discharge approximately 48 hours later (transition to acute care). Resolution of critical illness will be quantified by serial daily measures of composite organ dysfunction.
Specific Aim 3. Ascertain that performance of SeptiCyteTM RAPID utilizing a point of care device at Seattle Children's will be equivalent to centralized assessment using SeptiCyteTM LAB.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INSI Cohort
- •Admitted to the PICU
- •New severe trauma OR
- •New thermal burns OR
- •Rheumatologic diagnoses OR
- •Post-initiation (or circuit change) of extracorporeal life support OR
- •Post anoxic-ischemic-reperfusion insults OR
- •Infants undergoing cardiac surgery with cardiopulmonary bypass OR
- •CAR-T cell therapy
- •Parents speak English or Spanish AND
- •Not previously enrolled in the GEODESIC investigation
- •Pediatric Bacterial Sepsis Cohort
- •Admitted to the PICU
- •Parents speak English or Spanish AND
- •Exhibit SIRS criteria including at least fever/hypothermia or leukocytosis/leukopenia or left shift on the leukocyte differential AND
- •Strongly suspected or documented source of bacterial infection per primary care team
- •Not previously enrolled in the GEODESIC investigation
- •Pediatric Bacterial Sepsis Cohort
- •Admitted to the PICU
- •Parents speak English or Spanish AND
- •Positive PCR or culture verifying a viral infection
- •Not previously enrolled in the GEODESIC investigation
排除标准
- •Not expected to survive the PICU stay
- •Child has 'ward of the state' status
结局指标
主要结局
mRNA expression
时间窗: At PICU admission and 48 hours later
SeptiCyte (various) gene expression scores
次要结局
未报告次要终点