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

NCT04031794 | Unknown

• 1 other identifier: Si 203/2018
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Distress Syndrome; Refractory Hypoxemia

Keywords

Veno-venous ECMO; Severe ARDS; Refractory Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Hospital outcome

  Patient survive until discharge

  at least 90 days

Secondary Outcomes (1)

• 28 days mortality

  28 days

Study Arms (2)

Conventional ARDS treatment group

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

ECMO group

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

Device: Extra Corporeal Membrane Oxygenator (ECMO)

Interventions

Extra Corporeal Membrane Oxygenator (ECMO) DEVICE

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

ECMO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult severe ARDS with refractory hypoxemia

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (5)

• 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.

  PMID: 19822628 BACKGROUND

• 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.

  PMID: 21976615 BACKGROUND

• 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.

  PMID: 19762075 BACKGROUND

• 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.

  PMID: 35280476 DERIVED

• 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.

  PMID: 32603248 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Surat Tongyoo, Dr.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surat Tongyoo, Dr.

CONTACT

0820137771; surat.ton@mahidol.ac.th

Chairat Permpikul, Dr.

CONTACT

chairat.per@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: July 22, 2019
• Primary Completion: July 30, 2025
• Study Completion: July 31, 2025
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available per request
• Access Criteria: For meta-analysis

Locations

TH (1)