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

Completed

• Conditions: ARDS
• Interventions: Procedure: ECMO

• Registration Number: NCT04710173
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARDS children	ECMO	children with severe ARDS

Primary Outcome Measures

Name	Time	Method
Survival rate	28 days after hospital discharge	The survival rate of children in 28 days after hospital discharge

Secondary Outcome Measures

Name	Time	Method
ECMO weaning rate	48 hours after ECMO weaning	The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours

Trial Locations

Locations (3)

Guangdong Provincial People's Hospital; 🇨🇳 Guanzhou, China

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, China