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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Acute Respiratory Distress Syndrome; Refractory Hypoxemia
• Intervention / Treatment: Device: Extra Corporeal Membrane Oxygenator (ECMO)

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Surat Tongyoo, Dr.; Phone Number: 0820137771; Email: surat.ton@mahidol.ac.th
• Study Contact Backup: Name: Chairat Permpikul, Dr.; Email: chairat.per@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Siriraj Hospital
      • Contact: Chairat Permpikul, Dr.; Email: chairat.per@mahidol.ac.th
      • Contact: Surat Tongyoo, Dr.; Phone Number: 820137771; Email: surat.ton@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult severe ARDS with refractory hypoxemia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital outcome	Patient survive until discharge	at least 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 days mortality	Patient who dead before 28 days	28 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Surat Tongyoo, Dr., Mahidol University

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Lancet. 2009 Oct 17;374(9698):1330.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Anticipated): July 30, 2025
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Veno-venous ECMO; Severe ARDS; Refractory Hypoxemia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Shock; Hypoxia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Si 203/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with no patient identified number.
• IPD Sharing Time Frame: Data will be available per request
• IPD Sharing Access Criteria: For meta-analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No