An Observational Phase 0 Study to Assess the Performance and Real-world Feasibility of Implementing the MicroKine Dx Biomarker-based Risk Stratification of Critically-ill Pediatric Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 主要终点
- Mortality
研究概览
简要总结
This study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.
详细描述
This study will enroll approximately 25 pediatric patients to assess the predictive performance of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.
All enrolled patients will undergo a series of blood collection procedures during their admission to the pediatric intensive care unit. The levels of inflammatory cytokines, chemokines, and effectors will be assessed and used in multi-biomarker based prognostic and predictive algorithms to determine patients at risk of in-hospital mortality.
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
- 38 Weeks 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 38 weeks gestation to 21 years of age
- •Admitted to the PICU within the prior 24 hours
- •Indwelling catheters for obtaining blood
- •Meet ≥2 age-adapted SIRS criteria
排除标准
- •Anticipated pediatric intensive care unit admission <24 hours
- •Primary immunodeficiency
- •Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Mortality
时间窗: 28-day
28-day in hospital mortality
次要结局
未报告次要终点