Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-06 @ 6:08 PM
Study NCT ID:
NCT04480060
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2020-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2020-07-18', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality of the COVID-19 patients', 'timeFrame': '3 months', 'description': 'Mortality of the COVID-19 patients who followed up by emergency department ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.', 'detailedDescription': 'COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Emergency departments also carried out an important part of the fight against pandemics in our country/Turkey. The emergency department including an intensive care unit is very few in this country/Turkey and the only hospital, which has an Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Throughout the pandemic, many patients, including COVID-19 patients, were successfully followed up and discharged from EICU. With this study, the investigators expect to show the role of EICU during the pandemic. In addition, it will be seen that whether the patients, who are waiting for hospitalization or waiting for referral, are admitted to EICU faster and their treatments will be started promptly. Therefore, this retrospective study aimed to provide useful information about how an effective EICU should be, especially how to use them during pandemic periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients who followed up in emergency department ICU's of study centers with the diagnosis of COVID-19", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who followed up in emergency department ICU with the diagnosis of COVID-19\n* Accepted to participate with an informed consent\n\nExclusion Criteria:\n\n* Patients under the age of 18 or more than 50 years\n* declined to participate\n* deaths caused by other than COVID-19'}, 'identificationModule': {'nctId': 'NCT04480060', 'briefTitle': 'Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic: Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'KSSEAH--EDCC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COVID-19 diagnostic PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nasopharyngeal swab samples will be analyzed by PCR for COVID-19 DNA existence.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Seda Yilmaz Semerci', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ramazan Guven', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}