Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 10:02 PM
Study NCT ID:
NCT05279469
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in COVID-19m Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-12', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-03-12', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28 days mortality', 'timeFrame': '1 month', 'description': 'Outcomes of ICU stay'}], 'secondaryOutcomes': [{'measure': 'length of stay and mechanical ventilation', 'timeFrame': 'during ICU stay', 'description': 'time of admission and need to escalate oxygen therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['D dimer', 'SARS-COV-2'], 'conditions': ['Critical Illness', 'Pneumonia, Viral']}, 'descriptionModule': {'briefSummary': 'Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.', 'detailedDescription': 'Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.\n\nIt has been reported that COVID 19 is associated with hemostatic abnormalities and elevated D-Dimer level, so its level is used to predict severity of disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in SARS.COV.2 patients in ICU with positive PCR and needing oxygen therapy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of both sex admitted in icu\n* positive PCR\n* requiring oxygen therapy\n\nExclusion Criteria:\n\n* ward patients\n* negative PCR'}, 'identificationModule': {'nctId': 'NCT05279469', 'acronym': 'COVID-19', 'briefTitle': 'D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in COVID-19m Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'D-Dimer as Predictor of Disease Outcome in Intensive Care Unit in SARS-COV-2 Patients: A Retrospective Study', 'orgStudyIdInfo': {'id': 'MS56/2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention, just observational for D-Dimer level in blood', 'type': 'OTHER', 'description': 'observation for basal D-Dimer and 48 hours later D-Dimer in blood for ICU SARS.COV.2 patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amr M Hilal Abdou', 'investigatorAffiliation': 'Ain Shams University'}}}}