Study on the Efficacy and Timing of Extracorporeal Membrane Oxygenation (ECMO) Therapy in Children With Refractory Septic
概览
- 阶段
- 不适用
- 干预措施
- septic shock
- 疾病 / 适应症
- Septic Shock
- 发起方
- Children's Hospital of Fudan University
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Survival rate
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
Severe sepsis and septic shock remain the leading causes of child mortality worldwide. Sepsis is a complex process that ultimately leads to circulation disorders, organ perfusion abnormalities, capillary leakage, tissue hypoxia, and organ failure. The difficulty of clinical treatment is microcirculation and mitochondrial dysfunction in septic shock. Once shock enters the stage of microcirculation failure, conventional treatment is ineffective. ECMO can effectively support the circulatory system and provide good oxygen delivery, but there are many controversies in clinical treatment. 1) whether ECMO can effectively improve the clinical prognosis of children with septic shock; 2) appropriate timing for ECMO intervention; 3) which key clinical factors affect the effect of ECMO treatment. This study intends to adopt a multi-center, prospective, non-randomized controlled trial design, and the main research hypothesis is whether ECMO treatment can improve the success of discharge survival of children with septic shock.
详细描述
In this study, a variety of statistical analysis methods will be used to screen the clinical indicators and truncation values suitable for starting ECMO, and to construct a comprehensive prediction model, so as to determine the basis for the optimal timing of ECMO treatment in the future. The efficacy of ScVO2, lactic acid, and vasoactive inotrope score (VIS) on the ECMO treatment timing will also be evaluated. This study aims to evaluate and improve the clinical application of ECMO in the treatment of sepsis in children
研究者
入排标准
入选标准
- •Children with septic shock and refractory septic shock admitted to the PICU of all the study centers
排除标准
- •Fatal chromosomal abnormalities (e.g., trisomy 13 or 18)
- •Uncontrolled bleeding
- •Irreversible brain damage
- •After allogeneic bone marrow transplantation
- •Weight less than 2.5kg or severe malnutrition
研究组 & 干预措施
septic shock
The critically ill children with septic shock (ss group)
refractory septic shock with ECMO
The critically ill children with refractory septic shock with ECMO treatment
干预措施: ECMO
refractory septic shock without ECMO
The critically ill children prediction model th refractory septic shock without ECMO treatment
结局指标
主要结局
Survival rate
时间窗: 28 days
The survival rate of children in 28 days after hospital discharge
次要结局
- ECMO weaning rate(48 hours)