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Recruiting NCT03948048

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

— Observational Septic Shock Extracorporeal Membrane Oxygenation Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECMO.
Who it may be relevant to
Registry conditions: Septic Shock, Extracorporeal Membrane Oxygenation Complication. Basic parameters: 29 Days — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Interventions

  • Device ECMO
    ECMO is used to intervene septic shock and refractory septic shock

Primary outcome measures

  • Survival rate [Time frame: 28 days]
Secondary outcome measures (1)
  • ECMO weaning rate [Time frame: 48 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Children'S Hosptial of Fuan University — Shanghai

Identifiers

NCT: NCT03948048 · fdpicu-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗