RecruitingNCT03948048

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

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


Sponsor

Children's Hospital of Fudan University

Enrollment

60 participants

Start Date

Aug 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 29 DaysMax Age: 18 Years

Inclusion Criteria1

  • • Children with septic shock and refractory septic shock admitted to the PICU of all the study centers

Exclusion Criteria5

  • 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

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Interventions

DEVICEECMO

ECMO is used to intervene septic shock and refractory septic shock


Locations(1)

Children'S Hosptial of Fuan University

Shanghai, China

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NCT03948048


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