Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-02 @ 2:51 AM
Study NCT ID:
NCT05274503
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection of acute respiratory distress syndrome', 'timeFrame': '2 weeks', 'description': 'hypoxia, incresed plateau pressure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Duration']}, 'descriptionModule': {'briefSummary': "Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is \\<10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients more than 20 years old, covid positive, mechanically ventilated', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* •Age: more than 20 years.\n\n * Gender: both males and females will be included.\n * Mechanically Ventilated patients.\n * COVID 19 confirmed diagnosis\n\nExclusion Criteria:\n\n* •Immunocompromised patients.\n\n * Oxygen saturation more than 95% without ventilation.\n * Malignancy.\n * Patients refuse to be enrolled in the study.'}, 'identificationModule': {'nctId': 'NCT05274503', 'briefTitle': 'Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Serum Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19', 'orgStudyIdInfo': {'id': 'soh-Med-22-1-27'}}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University, Faculty of Medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia and intensive care', 'investigatorFullName': 'Islam Mokhtar Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}