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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03948048
Enrollment
60
Registered
2019-05-13
Start date
2020-08-01
Completion date
2026-12-31
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation Complication, Septic Shock

Keywords

septic shock, children, ECMO, timing

Brief 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.

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

DEVICEECMO

ECMO is used to intervene septic shock and refractory septic shock

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
29 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survival rate28 daysThe survival rate of children in 28 days after hospital discharge

Secondary

MeasureTime frameDescription
ECMO weaning rate48 hoursThe success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours

Countries

China

Contacts

CONTACTGuoping Lu, Doctor
13788904150@163.com+8613788904150
CONTACTYe Cheng, Master
Cheng18017591034@163.com+8613816566641
PRINCIPAL_INVESTIGATORGuoping Lu, Doctor

Children's Hospital of Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026