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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2020年8月1日

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

注册库
clinicaltrials.gov
开始日期
2020年8月1日
结束日期
2026年12月31日
最后更新
上个月
研究类型
Observational
性别
All

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)

研究点 (1)

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