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

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03948048

Collaborator

Shanghai Children's Hospital (Other), Beijing Children's Hospital (Other), Zhengzhou Children's Hospital, China (Other), Chinese PLA General Hospital (Other), The Children's Hospital of Zhejiang University School of Medicine (Other), Children's Hospital of Chongqing Medical University (Other), Shengjing Hospital (Other)

Enrollment

Location

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock Extracorporeal Membrane Oxygenation Complication	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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Study on the Efficacy and Timing of Extracorporeal Membrane Oxygenation (ECMO) Therapy in Children With Refractory Septic

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Survival rate [28 days]
The survival rate of children in 28 days after hospital discharge

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

29 Days to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children'S Hosptial of Fuan University	Shanghai		China

Sponsors and Collaborators

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

Investigators

Principal Investigator: Guoping Lu, Doctor, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT03948048

Other Study ID Numbers:

fdpicu-03

First Posted:

May 13, 2019

Last Update Posted:

Apr 12, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Children's Hospital of Fudan University

Additional relevant MeSH terms:

Shock, Septic

Shock

Study Results

No Results Posted as of Apr 12, 2022