Evaluating ECMO therapy timing for children with septic shock
Official title: Study on the Efficacy and Timing of Extracorporeal Membrane Oxygenation (ECMO) Therapy in Children With Refractory Septic
Run by Children's Hospital of Fudan University · NCT03948048 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 29 Days to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | August 1, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT03948048 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children with septic shock or refractory septic shock admitted to the Pediatric Intensive Care Unit (PICU).
✕Probably not a fit
Patients with fatal chromosomal abnormalities, uncontrolled bleeding, irreversible brain damage, or severe malnutrition may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
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This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.