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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2026-12-31

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.

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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

Conditions

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Septic Shock Extracorporeal Membrane Oxygenation Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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septic shock

The critically ill children with septic shock (ss group)

No interventions assigned to this group

refractory septic shock with ECMO

The critically ill children with refractory septic shock with ECMO treatment

ECMO

Intervention Type DEVICE

ECMO is used to intervene septic shock and refractory septic shock

refractory septic shock without ECMO

The critically ill children prediction model th refractory septic shock without ECMO treatment

No interventions assigned to this group

Interventions

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ECMO

ECMO is used to intervene septic shock and refractory septic shock

Intervention Type DEVICE

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

Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No