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临床试验/NCT03654287
NCT03654287撤回不适用

Exploring and Establishment of Multiple Organ Support Therapy(CELS)in Critically Ill Children

Guoping Lu1 个研究点 分布在 1 个国家开始时间: 2018年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
survival rate

研究概览

简要总结

Multiple organ failure (MODS) is still the leading cause of death in children in ICU. The treatment of MODS is mainly organ function monitoring and organ replacement therapy. Life support technology in vitro mainly includes mechanical ventilation, continuous renal replacement therapy (CRRT), non-biological artificial liver and extracorporeal membrane oxygenation technology (ECMO). However, critically ill patients who have multiple organ failure often require multiple organ support meanwhile. Combined extracorporeal life support (CELS) is still in its infancy to be applied in the treatment of critical illness due to nonstandard technology and theory without key breakthroughs and evidence-based medicine in the treatment of severe children organ failure.Solving the system problems supported by CELS can effectively reduce the mortality and disability rate of critically ill children and enhance health care in Shanghai, even across China.

详细描述

The whole study is described below. To investigate the timing ,curative effect and mode of CRRT and ECMO treatment for critically ill children,we choose sepsis children especially those who are combined with septic shock as research object.

Furthermore,refractory shock is the therapeutic indications of ECMO. According to their clinical manifestation and severity of the disease,they are treated by CRRT or/with ECMO in a non-randomized way.

Comparing the laboratory index and prognosis of critically ill children treated by CRRT and those treated by ECMO,we aim to investigate the the timing ,curative effect of ECMO in the treatment of septic shock especially refractory shock.

The critically ill children who treated by CRRT are divided into three groups according to their treatment mode of CRRT. The laboratory index and prognosis are also be compared to investigate curative effect of CRRT in the treatment of septic shock.

The study also include severe sepsis children without CRRT or ECMO treatment as a control group.

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 severe sepsis and refractory shock admitted to the PICU of four study centers.
  • The informed consent of the guardians

排除标准

  • active hemorrhage difficult catheter placing Irreversible brain damage patients enrolled in other clinic trial

结局指标

主要结局

survival rate

时间窗: 28 days

The survival rate of children in 28 days after their hospital discharged.

次要结局

  • ECMO weaning rate(48 hours)
  • Pediatric Risk of Mortality score (PRISM III)(the first 24 hours after admitted to PICU)

研究者

发起方
Guoping Lu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guoping Lu

Director of pediatric Emergency and Critical Care Center. Children's Hospital Fudan University;Director of AHA Training Center for pediatric life support. Children's Hospital Fudan University

Children's Hospital of Fudan University

研究点 (1)

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