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

NCT03948048 | Recruiting

• 1 other identifier: fdpicu-03
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Extracorporeal Membrane Oxygenation Complication

Keywords

septic shock; children; ECMO; timing

Outcome Measures

Primary Outcomes (1)

• Survival rate

  The survival rate of children in 28 days after hospital discharge

  28 days

Secondary Outcomes (1)

• ECMO weaning rate

  48 hours

Study Arms (3)

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

refractory septic shock without ECMO

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

Interventions

ECMO DEVICE

ECMO is used to intervene septic shock and refractory septic shock

refractory septic shock with ECMO

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Children with septic shock and refractory septic shock admitted to the PICU of all the study centers

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Children'S Hosptial of Fuan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Guoping Lu, Doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoping Lu, Doctor

CONTACT

+8613788904150; 13788904150@163.com

Ye Cheng, Master

CONTACT

+8613816566641; Cheng18017591034@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 13, 2019
• Study Start: August 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)