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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29-18
SponsorChildren's Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Fatal chromosomal abnormalities (e.g., trisomy 13 or 18)

Uncontrolled bleeding

Irreversible brain damage

After allogeneic bone marrow transplantation

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • ECMO

    Device

    ECMO is used to intervene septic shock and refractory septic shock

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: septic shock0 interventions
Group B: refractory septic shock with ECMO1 intervention
Group C: refractory septic shock without ECMO0 interventions

Trial outcomes

Primary outcomes

1

Survival rate

The survival rate of children in 28 days after hospital discharge

Time frame
28 days

Secondary outcomes

1

ECMO weaning rate

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

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Fudan University

Lead sponsor

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