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NCT Number: NCT03948048

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

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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Key information

Conditions

Septic Shock Extracorporeal Membrane Oxygenation Complication Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children'S Hosptial of Fuan University

Shanghai, China

Location status: Recruiting

Location contact

LU guoping, dotor

CONTACT

[email protected]

18017590817

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECMO

Device

ECMO is used to intervene septic shock and refractory septic shock

Primary outcomes

  1. Survival rate

    Time frame: 28 days

    The survival rate of children in 28 days after hospital discharge

Secondary outcomes

  1. ECMO weaning rate

    Time frame: 48 hours

    The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Guoping Lu, Doctor

CONTACT

[email protected]

+8613788904150

Ye Cheng, Master

CONTACT

[email protected]

+8613816566641

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Beijing Children's Hospital
  • Children's Hospital of Chongqing Medical University
  • Chinese PLA General Hospital
  • Shanghai Children's Hospital
  • Shengjing Hospital
  • The Children's Hospital of Zhejiang University School of Medicine
  • Zhengzhou Children's Hospital, China

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 13, 2019
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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