About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Fatal chromosomal abnormalities (e.g., trisomy 13 or 18)
Uncontrolled bleeding
Irreversible brain damage
After allogeneic bone marrow transplantation
Trial population
Children with septic shock and refractory septic shock admitted to the pediatric intensive care unit(PICU) of all the study centers
Trial design
Case-control
Prospective
Treatments tested in this trial
ECMO
DeviceECMO is used to intervene septic shock and refractory septic shock
Treatment groups
Trial outcomes
Primary outcomes
Survival rate
The survival rate of children in 28 days after hospital discharge
Secondary outcomes
ECMO weaning rate
The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours
Sponsors and contacts
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Children's Hospital of Fudan University
Lead sponsor
Shanghai Children's Hospital
Collaborator
Beijing Children's Hospital
Collaborator
Zhengzhou Children's Hospital, China
Collaborator
Chinese PLA General Hospital
Collaborator
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
Children's Hospital of Chongqing Medical University
Collaborator
Shengjing Hospital
Collaborator