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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Device: ECMO

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Guoping Lu, Doctor; Phone Number: +8613788904150; Email: 13788904150@163.com
• Study Contact Backup: Name: Ye Cheng, Master; Phone Number: +8613816566641; Email: Cheng18017591034@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Children'S Hosptial of Fuan University
    • Contact: LU guoping, dotor; Phone Number: 18017590817; Email: 13788904150@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with septic shock and refractory septic shock admitted to the pediatric intensive care unit（PICU） of all the study centers

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
septic shock; The critically ill children with septic shock (ss group)
refractory septic shock with ECMO; The critically ill children with refractory septic shock with ECMO treatment	Device: ECMO; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	The survival rate of children in 28 days after hospital discharge	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECMO weaning rate	The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours	48 hours

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Chinese PLA General Hospital; Shengjing Hospital; Shanghai Children's Hospital; Beijing Children's Hospital; The Children's Hospital of Zhejiang University School of Medicine; Zhengzhou Children's Hospital, China; Children's Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Guoping Lu, Doctor, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; children; ECMO; timing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Shock, Septic
• Other Study ID Numbers: fdpicu-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No