Septic ShockNCT03948048
Study on the Efficacy and Timing of ECMO Therapy in Children With Refractory Septic Shock
An observational study of Septic Shock and Extracorporeal Membrane Oxygenation Complication, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Septic Shock, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- ECMO
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with septic shock and refractory septic shock admitted to the pediatric intensive care unit（PICU） of all the study centers
Who may be able to join
- Children with septic shock and refractory septic shock admitted to the PICU of all the study centers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children'S Hosptial of Fuan University
Shanghai
LU guoping, dotor, 18017590817, 13788904150@163.com
About this study
Official title: Study on the Efficacy and Timing of Extracorporeal Membrane Oxygenation (ECMO) Therapy in Children With Refractory Septic
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.
Read the 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
- Being tested
- ECMO
- Keywords
- septic shock, children, ECMO, timing
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMODevice
ECMO is used to intervene septic shock and refractory septic shock
| Study group | Role | What they receive |
|---|---|---|
| septic shock | The critically ill children with septic shock (ss group) | |
| refractory septic shock with ECMO | The critically ill children with refractory septic shock with ECMO treatment Receives: Device: ECMO | |
| refractory septic shock without ECMO | The critically ill children prediction model th refractory septic shock without ECMO treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
The survival rate of children in 28 days after hospital discharge
Measured: 28 days
Secondary outcomes (1)
ECMO weaning rate
The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Aug 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital, Beijing Children's Hospital, Zhengzhou Children's Hospital, China, Chinese PLA General Hospital, The Children's Hospital of Zhejiang University School of Medicine, Children's Hospital of Chongqing Medical University, Shengjing Hospital
- Responsible party
- Sponsor
- Investigators
- Guoping Lu, Doctor, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948048
- Sponsor's protocol ID
- fdpicu-03
- Status last verified
- Mar 2026
- First submitted
- 10 May 2019
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Timing of Extracorporeal Membrane Oxygenation (ECMO) Therapy in Children With Refractory Septic
- ClinicalTrials.gov ID
- NCT03948048
- Acronym / sponsor ID
- fdpicu-03
- Keywords
- septic shock, children, ECMO, timing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital, Beijing Children's Hospital, Zhengzhou Children's Hospital, China, Chinese PLA General Hospital, The Children's Hospital of Zhejiang University School of Medicine, Children's Hospital of Chongqing Medical University, Shengjing Hospital
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| septic shock | – | –The critically ill children with septic shock (ss group) |
| refractory septic shock with ECMO | – | Device: ECMOThe critically ill children with refractory septic shock with ECMO treatment |
| refractory septic shock without ECMO | – | –The critically ill children prediction model th refractory septic shock without ECMO treatment |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with septic shock and refractory septic shock admitted to the pediatric intensive care unit（PICU） of all the study centers
Key inclusion criteria (1 listed)
- Children with septic shock and refractory septic shock admitted to the PICU of all the study centers
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMOECMO is used to intervene septic shock and refractory septic shock | Device | refractory septic shock with ECMO |
Primary outcome
Survival rate
Time frame: 28 days
The survival rate of children in 28 days after hospital discharge
1 secondary outcome
ECMO weaning rate
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoping Lu, Doctor principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Extracorporeal Membrane Oxygenation Complication, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoping Lu, Doctor (+8613788904150, 13788904150@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.