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ECMO for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure

M

Mahidol University

Status

Enrolling

Conditions

Refractory Hypoxemia
Severe Acute Respiratory Distress Syndrome

Treatments

Device: Extra Corporeal Membrane Oxygenator (ECMO)

Study type

Observational

Funder types

Other

Identifiers

NCT04031794
Si 203/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Conventional ARDS treatment group
Description:
Patients who they or their 1st degree relative refuse to initiate ECMO. They will receive conventional ARDS treatment.
ECMO group
Description:
Patients who ECMO is initiated for treat refractory hypoxemia. They will receive conventional ARDS treatment and ECMO support
Treatment:
Device: Extra Corporeal Membrane Oxygenator (ECMO)

Trial contacts and locations

1

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Central trial contact

Chairat Permpikul, Dr.; Surat Tongyoo, Dr.

Data sourced from clinicaltrials.gov

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