Evaluating ECMO therapy timing for children with septic shock
Study on the Efficacy and Timing of Extracorporeal Membrane Oxygenation (ECMO) Therapy in Children With Refractory Septic
Children's Hospital of Fudan University · NCT03948048
This study is testing the best timing for using ECMO therapy in children with severe septic shock to see if it can improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 29 Days to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT03948048 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and optimal timing of Extracorporeal Membrane Oxygenation (ECMO) therapy in children suffering from refractory septic shock. It employs a multi-center, prospective, non-randomized controlled design to analyze various clinical indicators that may influence ECMO treatment outcomes. The research aims to develop a prediction model to determine the best timing for ECMO intervention, assessing factors such as ScVO2, lactic acid levels, and vasoactive inotrope scores. The ultimate goal is to enhance the clinical application of ECMO in pediatric sepsis management.
Who should consider this trial
Good fit: Ideal candidates for this study are children with septic shock or refractory septic shock admitted to the Pediatric Intensive Care Unit (PICU).
Not a fit: Patients with fatal chromosomal abnormalities, uncontrolled bleeding, irreversible brain damage, or severe malnutrition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates and clinical outcomes for children with septic shock.
How similar studies have performed: While ECMO has been used in various contexts, this specific approach to timing and efficacy in pediatric septic shock is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai
- Children'S Hosptial of Fuan University — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Guoping Lu, Doctor — Children's Hospital of Fudan University
- Study coordinator: Guoping Lu, Doctor
- Email: 13788904150@163.com
- Phone: +8613788904150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Septic Shock, Extracorporeal Membrane Oxygenation Complication, septic shock, children, ECMO, timing