ARDSNCT04710173
Establishment of a Early Risk Model of ECMO in Children With ARDS
An observational study of ARDS, run by Children's Hospital of Fudan University at 3 sites in China.
Trial summary
The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. It has been an important part of the rescue treatment for ARDS. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- ARDS
- What is being tested?
- ECMO
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2018to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with acute respiratory distress syndrome（ARDS） admitted to the pediatric intensive care unit（PICU） of all the study centers
Who may be able to join
- Acute onset; within 7 days of clinical insult
- Chest imaging (radiograph or computed tomography) findings of new infiltrates (unilateral or bilateral) consistent with acute parenchymal disease
- Edema not fully explained by fluid overload or cardiac failure
- May present as new acute lung disease in setting of chronic lung disease and/or heart disease
- OI≥16
- Viral etiology is clear
Who cannot join
- Perinatal lung disease
- Large intracranial bleed with mass effect or need for neurosurgical intervention
- Hypoxic cardiac arrest without adequate CPR
- Irreversible underlying cardiac or lung pathology (and not a transplant candidate)
- Pulmonary hypertension and chronic lung disease
- Chronic multiorgan dysfunction
Show all 12Show fewer
- Incurable malignancy
- Allogenic bone marrow recipients with pulmonary infiltrates
- Hepatic or renal failure
- Pertussis infection in infants
- Fungal pneumonia
- Immunodeficiency
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chinese PLA General Hospital
Beijing
Children's Hospital of Chongqing Medical University
Chongqing
Guangdong Provincial People's Hospital
Guanzhou
About this study
Official title: Establishment of a Early Risk Model of Extracorporeal Membrane Oxygenation（ECMO） in Children With Acute Respiratory Distress Syndrome （ARDS） in China
The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. It has been an important part of the rescue treatment for ARDS. This study intends to explore the timing of ECMO. The main research hypothesis is that the appropriate timing of ECMO treatment can improve the weaning success rate and survival rate of children with severe ARDS; it is expected to provide a basis for determining the best timing of ECMO treatment
Read the detailed description
Severe acute respiratory distress syndrome (ARDS), especially those caused by severe viral pneumonia, is still an important factor in the death of children, with a case fatality rate of 55%. The treatment includes lung protective ventilation and advanced ventilation support, but the effect is still not ideal for severe patients. ECMO can effectively support the respiratory system and provide good oxygen exchange. However, the survival rate of ECMO treatment in children with ARDS has a large bias.One of the key factors is the uneven timing of ECMO activation, which significantly affects the prognosis.This study intends to design a multi-center, prospective, non-randomized controlled trial , through retrospective research to find relevant factors affecting the prognosis of ECMO treatment, and to screen key indicators related to the timing of intervention; through a prospective cohort study to screen Good indicators and cut-off values suitable for starting ECMO , constructing and verifying comprehensive prediction models.
- Conditions
- ARDS
- Being tested
- ECMO
- Keywords
- ECMO, ARDS, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMOProcedure or surgery
VV-ECMO
| Study group | Role | What they receive |
|---|---|---|
| ARDS children | children with severe ARDS Receives: Procedure: ECMO |
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 after hospital discharge
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 after ECMO weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2018
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Children's Hospital of Chongqing Medical University, Guangdong Provincial People's Hospital, Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Ye Cheng, doctor, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710173
- Sponsor's protocol ID
- fdpicu-07
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Early Risk Model of Extracorporeal Membrane Oxygenation（ECMO） in Children With Acute Respiratory Distress Syndrome （ARDS） in China
- ClinicalTrials.gov ID
- NCT04710173
- Acronym / sponsor ID
- fdpicu-07
- Conditions
- ARDS
- Keywords
- ECMO, ARDS, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- The Children's Hospital of Zhejiang University School of Medicine, Children's Hospital of Chongqing Medical University, Guangdong Provincial People's Hospital, Chinese PLA General Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 14 Jan 2021 (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.
The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. It has been an important part of the rescue treatment for ARDS. This study intends to explore the timing of ECMO. The main research hypothesis is that the appropriate timing of ECMO treatment can improve the weaning success rate and survival rate of children with severe ARDS; it is expected to provide a basis for determining the best timing of ECMO treatment
Detailed description
Severe acute respiratory distress syndrome (ARDS), especially those caused by severe viral pneumonia, is still an important factor in the death of children, with a case fatality rate of 55%. The treatment includes lung protective ventilation and advanced ventilation support, but the effect is still not ideal for severe patients. ECMO can effectively support the respiratory system and provide good oxygen exchange. However, the survival rate of ECMO treatment in children with ARDS has a large bias.One of the key factors is the uneven timing of ECMO activation, which significantly affects the prognosis.This study intends to design a multi-center, prospective, non-randomized controlled trial , through retrospective research to find relevant factors affecting the prognosis of ECMO treatment, and to screen key indicators related to the timing of intervention; through a prospective cohort study to screen Good indicators and cut-off values suitable for starting ECMO , constructing and verifying comprehensive prediction models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS children | – | Procedure: ECMOchildren with severe ARDS |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with acute respiratory distress syndrome（ARDS） admitted to the pediatric intensive care unit（PICU） of all the study centers
Key inclusion criteria (6 listed)
- Acute onset; within 7 days of clinical insult
- Chest imaging (radiograph or computed tomography) findings of new infiltrates (unilateral or bilateral) consistent with acute parenchymal disease
- Edema not fully explained by fluid overload or cardiac failure
- May present as new acute lung disease in setting of chronic lung disease and/or heart disease
- OI≥16
Key exclusion criteria (12 listed)
- Perinatal lung disease
- Large intracranial bleed with mass effect or need for neurosurgical intervention
- Hypoxic cardiac arrest without adequate CPR
- Irreversible underlying cardiac or lung pathology (and not a transplant candidate)
- Pulmonary hypertension and chronic lung disease
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 |
|---|---|---|
| ECMOVV-ECMO | Procedure or surgery | ARDS children |
Primary outcome
Survival rate
Time frame: 28 days after hospital discharge
The survival rate of children in 28 days after hospital discharge
1 secondary outcome
ECMO weaning rate
Time frame: 48 hours after ECMO weaning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Related trials for ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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. This study is not recruiting at the moment.
Ye Cheng, doctor study director
Children's Hospital of Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, run by Children's Hospital of Fudan University at 3 sites 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 28 days after hospital discharge). 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 7 Feb 2024.