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

NCT04710173 | Completed

• 1 other identifier: fdpicu-07
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 3

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

Conditions

ARDS

Keywords

ECMO; ARDS; pediatric

Outcome Measures

Primary Outcomes (1)

• Survival rate

  The survival rate of children in 28 days after hospital discharge

  28 days after hospital discharge

Secondary Outcomes (1)

• ECMO weaning rate

  48 hours after ECMO weaning

Study Arms (1)

ARDS children

children with severe ARDS

Procedure: ECMO

Interventions

ECMO PROCEDURE

VV-ECMO

ARDS children

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• Children's Hospital of Chongqing Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Chinese PLA General Hospital: collaborator

Study Sites (3)

Chinese PLA General Hospital

Beijing, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, China

Location

Guangdong Provincial People's Hospital

Guanzhou, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

2 ml whole blood in EDTA tube

Study Officials

• Ye Cheng, doctor

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: January 1, 2018
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (3)