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

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation Complication; Septic Shock
• Interventions: Device: ECMO

• Registration Number: NCT03948048
• Lead Sponsor: Children's Hospital of Fudan University

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

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2020-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
refractory septic shock with ECMO	ECMO	The critically ill children with refractory septic shock with ECMO treatment

Primary Outcome Measures

Name	Time	Method
Survival rate	28 days	The survival rate of children in 28 days after hospital discharge

Secondary Outcome Measures

Name	Time	Method
ECMO weaning rate	48 hours	The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours

Trial Locations

Locations (1)

Children'S Hosptial of Fuan University; 🇨🇳 Shanghai, China