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NCT Number: NCT04710173

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

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

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Key information

Conditions

Age range

28 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ECMO

Procedure

VV-ECMO

Primary outcomes

  1. Survival rate

    Time frame: 28 days after hospital discharge

    The survival rate of children in 28 days after hospital discharge

Secondary outcomes

  1. ECMO weaning rate

    Time frame: 48 hours after ECMO weaning

    The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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