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

NCT ID: NCT04031794

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-22

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Severe Acute Respiratory Distress Syndrome Refractory Hypoxemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Conventional ARDS treatment group

Patients who they or their 1st degree relative refuse to initiate ECMO. They will receive conventional ARDS treatment.

No interventions assigned to this group

ECMO group

Patients who ECMO is initiated for treat refractory hypoxemia. They will receive conventional ARDS treatment and ECMO support

Extra Corporeal Membrane Oxygenator (ECMO)

Intervention Type DEVICE

Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.

Interventions

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Extra Corporeal Membrane Oxygenator (ECMO)

Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Surat Tongyoo, Dr.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Surat Tongyoo, Dr.

Role: CONTACT

0820137771

Chairat Permpikul, Dr.

Role: CONTACT

Facility Contacts

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Surat Tongyoo, Dr.

Role: primary

820137771

Chairat Permpikul, Dr.

Role: backup

References

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Australia and New Zealand Extracorporeal Membrane Oxygenation (ANZ ECMO) Influenza Investigators; Davies A, Jones D, Bailey M, Beca J, Bellomo R, Blackwell N, Forrest P, Gattas D, Granger E, Herkes R, Jackson A, McGuinness S, Nair P, Pellegrino V, Pettila V, Plunkett B, Pye R, Torzillo P, Webb S, Wilson M, Ziegenfuss M. Extracorporeal Membrane Oxygenation for 2009 Influenza A(H1N1) Acute Respiratory Distress Syndrome. JAMA. 2009 Nov 4;302(17):1888-95. doi: 10.1001/jama.2009.1535. Epub 2009 Oct 12.

Reference Type BACKGROUND
PMID: 19822628 (View on PubMed)

Noah MA, Peek GJ, Finney SJ, Griffiths MJ, Harrison DA, Grieve R, Sadique MZ, Sekhon JS, McAuley DF, Firmin RK, Harvey C, Cordingley JJ, Price S, Vuylsteke A, Jenkins DP, Noble DW, Bloomfield R, Walsh TS, Perkins GD, Menon D, Taylor BL, Rowan KM. Referral to an extracorporeal membrane oxygenation center and mortality among patients with severe 2009 influenza A(H1N1). JAMA. 2011 Oct 19;306(15):1659-68. doi: 10.1001/jama.2011.1471. Epub 2011 Oct 5.

Reference Type BACKGROUND
PMID: 21976615 (View on PubMed)

Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15.

Reference Type BACKGROUND
PMID: 19762075 (View on PubMed)

Tongyoo S, Chanthawatthanarak S, Permpikul C, Ratanarat R, Promsin P, Kongsayreepong S. Extracorporeal membrane oxygenation (ECMO) support for acute hypoxemic respiratory failure patients: outcomes and predictive factors. J Thorac Dis. 2022 Feb;14(2):371-380. doi: 10.21037/jtd-21-1460.

Reference Type DERIVED
PMID: 35280476 (View on PubMed)

Tongyoo S, Permpikul C, Sucher S, Thomrongpairoj P, Poompichet A, Ratanarat R, Chierakul N. Venovenous extracorporeal membrane oxygenation versus conventional mechanical ventilation to treat refractory hypoxemia in patients with acute respiratory distress syndrome: a retrospective cohort study. J Int Med Res. 2020 Jun;48(6):300060520935704. doi: 10.1177/0300060520935704.

Reference Type DERIVED
PMID: 32603248 (View on PubMed)

Other Identifiers

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Si 203/2018

Identifier Type: -

Identifier Source: org_study_id

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