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临床试验/NCT03948048
NCT03948048招募中不适用

Study on the Efficacy and Timing of Extracorporeal Membrane Oxygenation (ECMO) Therapy in Children With Refractory Septic

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Survival rate

研究概览

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
29 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

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 (Device)

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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