Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-06 @ 10:28 PM
Study NCT ID:
NCT04031794
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital outcome', 'timeFrame': 'at least 90 days', 'description': 'Patient survive until discharge'}], 'secondaryOutcomes': [{'measure': '28 days mortality', 'timeFrame': '28 days', 'description': 'Patient who dead before 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Veno-venous ECMO', 'Severe ARDS', 'Refractory Hypoxemia'], 'conditions': ['Severe Acute Respiratory Distress Syndrome', 'Refractory Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '19822628', 'type': 'BACKGROUND', 'citation': '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': '21976615', 'type': 'BACKGROUND', 'citation': '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': '19762075', 'type': 'BACKGROUND', 'citation': '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': '35280476', 'type': 'DERIVED', 'citation': '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': '32603248', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nPatients 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.\n\nThe patients in both groups will be follow up until they are discharged from the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult severe ARDS with refractory hypoxemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed ARDS according to Berlin criteria\n* Refractory hypoxemia: PaO2/FiO2 \\<100 with FiO2 \\>90% despite optimal mechanical ventilator support and paralytic agent infusion\n* Hypoxemia persist for at least 2 hours\n\nExclusion Criteria:\n\n* Terminally ill patient\n* Patient who sign for do not resuscitation\n* Metastatic malignancy'}, 'identificationModule': {'nctId': 'NCT04031794', 'briefTitle': 'ECMO for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Extracorporeal Membrane Oxygenator (ECMO) for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure', 'orgStudyIdInfo': {'id': 'Si 203/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional ARDS treatment group', 'description': 'Patients who they or their 1st degree relative refuse to initiate ECMO. They will receive conventional ARDS treatment.'}, {'label': 'ECMO group', 'description': 'Patients who ECMO is initiated for treat refractory hypoxemia. They will receive conventional ARDS treatment and ECMO support', 'interventionNames': ['Device: Extra Corporeal Membrane Oxygenator (ECMO)']}], 'interventions': [{'name': 'Extra Corporeal Membrane Oxygenator (ECMO)', 'type': 'DEVICE', 'description': 'Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.', 'armGroupLabels': ['ECMO group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Surat Tongyoo, Dr.', 'role': 'CONTACT', 'email': 'surat.ton@mahidol.ac.th', 'phone': '820137771'}, {'name': 'Chairat Permpikul, Dr.', 'role': 'CONTACT', 'email': 'chairat.per@mahidol.ac.th'}], 'facility': 'Siriraj Hospital'}], 'centralContacts': [{'name': 'Surat Tongyoo, Dr.', 'role': 'CONTACT', 'email': 'surat.ton@mahidol.ac.th', 'phone': '0820137771'}, {'name': 'Chairat Permpikul, Dr.', 'role': 'CONTACT', 'email': 'chairat.per@mahidol.ac.th'}], 'overallOfficials': [{'name': 'Surat Tongyoo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available per request', 'ipdSharing': 'YES', 'description': 'Data will be shared with no patient identified number.', 'accessCriteria': 'For meta-analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}