External validation of phoenix score for sepsis in critically ill children: a single-center, prospective cohort study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
EPICS-V Study: External Validation of Phoenix Sepsis Score in Critically Ill ChildrenAim: To prospectively validate the Phoenix Sepsis Score (PSS) in discriminating mortality among critically ill children with suspected sepsis in an Indian PICU setting.
Background: The Phoenix Sepsis Score (PSS), developed in 2024, offers an organ dysfunction-based approach for pediatric sepsis, showing improved mortality prediction. However, external validation in diverse settings, especially in India, is crucial for its broader applicability.
Design: A single-centre, prospective observational cohort study.
Setting: Pediatric Intensive Care Unit (PICU), All India Institute of Medical Sciences (AIIMS), Raipur, India.
Participants: Children aged 1 month to 15 years admitted to PICU with suspected sepsis. Exclusions include CPR at admission or PICU stay less than 24 hours.
Data Collection: Clinical and laboratory parameters will be collected within the initial 72 hours of admission, at defined time blocks (0-6h, 6-24h, 24-36h, 36-48h, 48-72h), using the worst values observed. PSS, PSS-8, and PELOD-2 scores will be calculated.
Outcomes:
- Primary: 28-day mortality.
- Secondary: Early death within 72 hours.
Analysis: Mortality discrimination will be assessed using AUROC (primary) and AUPRC (secondary). Comparisons between PSS, PSS-8, and PELOD-2 will also be performed.
Ethics: Approved by the Institutional Ethics Committee (IEC) of AIIMS Raipur. Informed consent will be obtained from parents/guardians. Data collection is for research only and will not alter clinical management.
Expected Completion: Within 18 months from IEC approval.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Suspected sepsis, operationalized as presence of a systemic antimicrobial (i.e. antibacterials, antimalarials, antimycotics, antivirals, antimycobacterial, or anthelmintics) and microbiological testing (bacterial and fungal cultures, viral testing, parasite testing, etc.) within the same 24-hour period.
排除标准
- •1.Cardiopulmonary Resuscitation (CPR): Requirement of CPR at the time of admission to the PICU.
- •2.Duration of PICU Stay less than 24 hours.
结局指标
主要结局
Mortality
时间窗: within 28-days of suspected sepsis.
次要结局
- Mortality(within 72-hours of suspected sepsis.)
研究者
Dr Dasari Divyamsu
AIIMS, Raipur