Study on the Efficacy and Timing of ECMO Therapy in Children With Refractory Septic Shock

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Septic Shock, Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
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* Device: ECMO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Children with septic shock and refractory septic shock admitted to the PICU of all the study centers Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| septic shock<br>The critically ill children with septic shock (ss group) | |
| refractory septic shock with ECMO<br>The critically ill children with refractory septic shock with ECMO treatment | Device: ECMO<br>* ECMO is used to intervene septic shock and refractory septic shock<br>|
| refractory septic shock without ECMO<br>The critically ill children prediction model th refractory septic shock without ECMO treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | The survival rate of children in 28 days after hospital discharge | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECMO weaning rate | The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, children, ECMO, timing