Clinical trial NCT04710173: Establishment of a Early Risk Model of ECMO in Children With ARDS
Official title: Establishment of a Early Risk Model of Extracorporeal Membrane Oxygenation（ECMO） in Children With Acute Respiratory Distress Syndrome （ARDS） in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Keywords: ECMO
ARDS
pediatric
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: The Children's Hospital of Zhejiang University School of Medicine
name: Children's Hospital of Chongqing Medical University
name: Guangdong Provincial People's Hospital
name: Chinese PLA General Hospital
First posted: 2021-01-14
Enrollment: 95
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with acute respiratory distress syndrome（ARDS） admitted to the pediatric intensive care unit（PICU） of all the study centers

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Incurable malignancy
* Allogenic bone marrow recipients with pulmonary infiltrates
* Hepatic or renal failure
* Pertussis infection in infants
* Fungal pneumonia
* Immunodeficiency

Primary outcomes:
measure: Survival rate
timeFrame: 28 days after hospital discharge
Secondary outcomes:
measure: ECMO weaning rate
timeFrame: 48 hours after ECMO weaning
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
city: Guanzhou
country: China
facility: Guangdong Provincial People's Hospital
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ye Cheng, doctor
role: STUDY_DIRECTOR
References: