NCT03948048

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 29 Days – 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Septic Shock
• Extracorporeal Membrane Oxygenation Complication

Interventions

Type	Name	Description
DEVICE	ECMO	ECMO is used to intervene septic shock and refractory septic shock

Timeline

• Start date: 2020-08-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-05-13
• Last updated: 2026-03-16

Locations

1 site across 1 country: China