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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948048
• Other study ID #: fdpicu-03
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Guoping Lu, Doctor
• Phone: +8613788904150
• Email: 13788904150[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication
• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• ECMO
ECMO is used to intervene septic shock and refractory septic shock

Locations

Country	Name	City	State
China	Children'S Hosptial of Fuan University	Shanghai

Sponsors (8)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	The survival rate of children in 28 days after hospital discharge	28 days
Secondary	ECMO weaning rate	The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours	48 hours