Establishment of a Early Risk Model of ECMO in Children With ARDS

ARDS Clinical Trial

Official title:

Establishment of a Early Risk Model of Extracorporeal Membrane Oxygenation（ECMO） in Children With Acute Respiratory Distress Syndrome （ARDS） in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710173
• Other study ID #: fdpicu-07
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS

Intervention

Procedure:
• ECMO
VV-ECMO

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	Children's Hospital of Chongqing Medical University	Chongqing
China	Guangdong Provincial People's Hospital	Guanzhou

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Children's Hospital of Chongqing Medical University, Chinese PLA General Hospital, Guangdong Provincial People's Hospital, The Children's Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	The survival rate of children in 28 days after hospital discharge	28 days after hospital discharge
Secondary	ECMO weaning rate	The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours	48 hours after ECMO weaning