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Clinical Trials/NCT04031794
NCT04031794
Recruiting
Not Applicable

Extracorporeal Membrane Oxygenator (ECMO) for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure

Mahidol University1 site in 1 country250 target enrollmentJuly 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Acute Respiratory Distress Syndrome
Sponsor
Mahidol University
Enrollment
250
Locations
1
Primary Endpoint
Hospital outcome
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Extracorporeal membrane oxygenation (ECMO) had been used to treat refractory hypoxemia associated with acute respiratory distress syndrome (ARDS). There were reported good outcome associated with ECMO for ARDS caused by influenza infection from several ECMO centers. However, the outcome of ECMO support in lower ECMO experience center had not been evaluated. This study aimed to evaluate the outcome of ECMO, comparing with conventional treatment among severe hypoxemic ARDS patients who were admitted in limited ECMO experience hospital.

Detailed Description

This registry enroll refractory hypoxemia ARDS patients who met the criteria for veno-venous ECMO, according to 2013 Extracorporeal Life Support Organization (ELSO) guideline criteria. The definition of refractory hypoxemia was partial pressure of oxygen:fraction of inspire oxygen (PaO2/FiO2) \<100 with fraction of inspire oxygen (FiO2) \>90% despite optimal mechanical ventilator support for at least 2 hours. The ECMO team was alerted for patient evaluation. The patients, who did not consider as ECMO candidate, due to their underlying condition of terminally illness, were excluded. The decision to initiate ECMO, or not, is dependent on the conference included the patient or the patient first relative, the attending physician and the ECMO team physicians. Patients who ECMO is initiated will be classified into ECMO group. Patients who they or their 1st degree relative do not agree for ECMO initiation will be treated according to standard treatment for ARDS, and classified in non-ECMO group. The patients in both groups will be follow up until they are discharged from the hospital.

Registry
clinicaltrials.gov
Start Date
July 22, 2019
End Date
July 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed ARDS according to Berlin criteria
  • Refractory hypoxemia: PaO2/FiO2 \<100 with FiO2 \>90% despite optimal mechanical ventilator support and paralytic agent infusion
  • Hypoxemia persist for at least 2 hours

Exclusion Criteria

  • Terminally ill patient
  • Patient who sign for do not resuscitation
  • Metastatic malignancy

Outcomes

Primary Outcomes

Hospital outcome

Time Frame: at least 90 days

Patient survive until discharge

Secondary Outcomes

  • 28 days mortality(28 days)

Study Sites (1)

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