Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
Study NCT ID:
NCT04411368
Status:
UNKNOWN
Last Update Posted:
2020-06-02
First Post:
2020-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nasopharyngeal aspirates, Sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-30', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-30', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of respiratory viral infections', 'timeFrame': 'within 24 hours after intensive care unit (ICU) admission', 'description': 'Rate of respiratory viral infections in patients with acute respiratory failure'}], 'secondaryOutcomes': [{'measure': 'ICU mortality rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Association between respiratory viral infections and death in ICU and risk factors of death in patients with ARF'}, {'measure': 'Hospital mortality rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Association between respiratory viral infections and death in hospital and risk factors of death in patients with ARF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure', 'Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with presentation to ICU with critical illness compatible with acute respiratory failrue.\n\n\\* Definition of acute respiratory failure: Patients who met one of following criteria\n\n1. SaO2 \\< 90% on room air\n2. SaO2 \\< 92% on \\> 6L/min of oxygen\n3. Respiratory rates \\> 30/min, or sign of respiratory distress', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged ≥ 19 years\n* Written informed consent by the patient or legally authorized representative\n* Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation\n\nExclusion Criteria:\n\n* No informed consent\n* A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability'}, 'identificationModule': {'nctId': 'NCT04411368', 'briefTitle': 'Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure', 'orgStudyIdInfo': {'id': 'ICU_RES_VIRUS'}}, 'contactsLocationsModule': {'locations': [{'zip': '06591', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jongmin Lee, M.D.', 'role': 'CONTACT', 'email': 'dibs03@gmail.com', 'phone': '82-10-6300-7128'}], 'facility': "Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jongmin Lee, Ph.D', 'role': 'CONTACT', 'email': 'dibs03@gmail.com', 'phone': '+821063007128'}], 'overallOfficials': [{'name': 'Jongmin Lee', 'role': 'STUDY_DIRECTOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Jongmin Lee', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}