Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT04508933
Status:
WITHDRAWN
Last Update Posted:
2021-10-26
First Post:
2020-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D055370', 'term': 'Lung Injury'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of Funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2020-08-08', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extravascular Lung Water Index', 'timeFrame': '1 day', 'description': 'The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)'}, {'measure': 'Pulmonary vascular permeability index', 'timeFrame': '1 day', 'description': 'Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ards', 'covid19'], 'conditions': ['Respiratory Distress Syndrome, Adult', 'Ventilation Perfusion Mismatch', 'Pulmonary Edema', 'Covid19']}, 'referencesModule': {'references': [{'pmid': '28625165', 'type': 'RESULT', 'citation': 'Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.'}]}, 'descriptionModule': {'briefSummary': 'Covid-19 also primarily affects endothelium that line up the alveoli. The resulting hypoxemia may differ from "typical" Acute Respiratory Distress Syndrome (ARDS) due to maldistribution of perfusion related to the ventilation. Thus, pathophysiology of Covid-19 ARDS is different, which requires different interventions than typical ARDS. The investigators will assess whether extravascular lung water index and permeability of the alveolar capillary differs from typical ARDS with transpulmonary thermodilution (TPTD) technique. Extravascular Lung Water Index (EVLWI) and Pulmonary Vascular Permeability Index (PVPI) will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with ARDS in the adult ICU that have a TPTD catheter inserted since 2018 will be eligible for recruitment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ARDS defined by Berlin Criteria longer than 24 hours\n* Undergoing mechanical ventilation\n* Noradrenaline demand \\>0.1 mcg/kg/min\n\nExclusion Criteria:\n\n* Not meeting ARDS criteria\n* Noninvasive mechanical ventilation\n* ARDS resolved shorter than 24 hours\n* Shock resolved'}, 'identificationModule': {'nctId': 'NCT04508933', 'briefTitle': 'Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients', 'orgStudyIdInfo': {'id': '0308202247'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Typical ARDS', 'description': 'ARDS due to non Covid19 causes', 'interventionNames': ['Device: Extravascular Lung Water Index', 'Device: Pulmonary Vascular Permeability Index']}, {'label': 'C-ARDS', 'description': 'ARDS due to Covid19', 'interventionNames': ['Device: Extravascular Lung Water Index', 'Device: Pulmonary Vascular Permeability Index']}], 'interventions': [{'name': 'Extravascular Lung Water Index', 'type': 'DEVICE', 'description': 'Measurement of the EVLWI', 'armGroupLabels': ['C-ARDS', 'Typical ARDS']}, {'name': 'Pulmonary Vascular Permeability Index', 'type': 'DEVICE', 'description': 'Measurement of the PVPI', 'armGroupLabels': ['C-ARDS', 'Typical ARDS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpaşa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yalım Dikmen, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data available on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Olcay Dilken', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}