NCT03948048 Study on the Efficacy and Timing of ECMO Therapy in Children With Refractory Septic Shock
| NCT ID | NCT03948048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Septic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2020-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Guoping Lu, Doctor
PRINCIPAL INVESTIGATOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT03948048 clinical trial?
This trial is open to participants of all sexes, aged 29 Days or older, up to 18 Years, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03948048 currently recruiting?
Yes, NCT03948048 is actively recruiting participants. Contact the research team at 13788904150@163.com for enrollment information.
Where is the NCT03948048 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT03948048 clinical trial?
NCT03948048 is sponsored by Children's Hospital of Fudan University. The principal investigator is Guoping Lu, Doctor at Children's Hospital of Fudan University. The trial plans to enroll 60 participants.