Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT01763060
Status:
COMPLETED
Last Update Posted:
2013-11-21
First Post:
2013-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Follow up of Patients Who Were Treated With Extracorporeal Membrane Oxygenation for Pandemic Influenza A/H1N1 Induced Severe Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-20', 'studyFirstSubmitDate': '2013-01-04', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung function', 'timeFrame': '3 years after ecmo treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ards', 'ecmo', 'h1n1', 'pandemics'], 'conditions': ['Long Term Outcome']}, 'referencesModule': {'references': [{'pmid': '28030441', 'type': 'DERIVED', 'citation': 'Holzgraefe B, Andersson C, Kalzen H, von Bahr V, Mosskin M, Larsson EM, Palmer K, Frenckner B, Larsson A. Does permissive hypoxaemia during extracorporeal membrane oxygenation cause long-term neurological impairment?: A study in patients with H1N1-induced severe respiratory failure. Eur J Anaesthesiol. 2017 Feb;34(2):98-103. doi: 10.1097/EJA.0000000000000544.'}]}, 'descriptionModule': {'briefSummary': 'Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or circulatory failure show severe long term disability due to impaired lung -, cerebral-, cognitive function and impaired quality of life. This study investigates the long term outcome of all patients who are still alive three years after ECMO treatment for severe respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who survived ECMO treatment due to infection with Influenza A/H1N1 2009 up to 3 years after discharge from hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Survivors of ECMO treatment for influenza a/h1n1 pneumonia during 2009/2010 pandemics at the ECMO Center Karolinska\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01763060', 'briefTitle': 'Long Term Follow up of Patients Who Were Treated With Extracorporeal Membrane Oxygenation for Pandemic Influenza A/H1N1 Induced Severe Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'orgStudyIdInfo': {'id': 'Dnr 2012/986-31/3'}, 'secondaryIdInfos': [{'id': 'Long term outcome', 'type': 'OTHER', 'domain': 'Ehtical committee Stockholm'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO survivors', 'description': 'CT scan of the chest of all ECMO survivors after 2009/2010 pandemics Tests for cognitive function MRI of the brain Lung function', 'interventionNames': ['Radiation: CT scan', 'Behavioral: Cognitive function', 'Radiation: MRI']}], 'interventions': [{'name': 'CT scan', 'type': 'RADIATION', 'armGroupLabels': ['ECMO survivors']}, {'name': 'Cognitive function', 'type': 'BEHAVIORAL', 'armGroupLabels': ['ECMO survivors']}, {'name': 'MRI', 'type': 'RADIATION', 'armGroupLabels': ['ECMO survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Uppsala University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Bernhard Holzgraefe', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}