Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 5:52 AM
Study NCT ID:
NCT04683094
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2020-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study for the Validity of Various Severity Scoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2020-12-20', 'studyFirstSubmitQcDate': '2020-12-20', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Physiology and Chronic Health Evaluation (APACHE) IV', 'timeFrame': 'the first 24 hours after ICU admission'}, {'measure': 'Simplified Acute Physiology Score (SAPS III)', 'timeFrame': 'the first 24 hours after ICU admission'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) score', 'timeFrame': 'the first 24 hours after ICU admission'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['APACH IV; SAPS III , SOFA score'], 'conditions': ['Head Trauma', 'Polytrauma', 'Pre-Eclampsia', 'Sepsis', 'Septic Shock']}, 'descriptionModule': {'briefSummary': 'Scoring systems for use in intensive care unit (ICU) patients have been introduced and developed over the last 30 years. They allow an assessment of the severity of disease and provide an estimate of in-hospital mortality', 'detailedDescription': 'Severity scoring systems that are commonly used in critical care settings include Acute Physiology and Chronic Health Evaluation (APACHE), which was developed in the 1980s for predicting mortality, Simplified Acute Physiology Score (SAPS), and Mortality Probability Model (MPM). Although these scoring systems use different variables and weights for the classification of disease severity, they commonly monitor parameters such as heart rate, blood pressure, neurological state, and clinical data as these factors significantly deviate from physiological normality in the progression of critical disease. Old age and chronic disease are also captured by the scoring systems. Sequential Organ Failure Assessment (SOFA) score, which is based on organ failure over time to evaluate morbidity and multiple organ dysfunction is also used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'newly admitted patients to the Surgical Intensive Care Unit at Aswan University Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly admitted patients to the Surgical Intensive Care Unit with head trauma multiple trauma craniotomy sepsis preeclampsia - eclampsia postop. for vascular surgery\n\nExclusion Criteria:\n\nless than 16 years old, readmitted to the ICU during the study period as only the first admission will be considered, ICU length of stay (LOS) less than 24 h'}, 'identificationModule': {'nctId': 'NCT04683094', 'briefTitle': 'Comparative Study for the Validity of Various Severity Scoring System', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Comparative Study for the Validity of Various Severity Scoring System in the Surgical Intensive Care Unit at Aswan University Hospital', 'orgStudyIdInfo': {'id': '449/3/20'}}, 'contactsLocationsModule': {'locations': [{'zip': '81511', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Huda Fahmy', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'huda fahmy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anesthesia and Intensive Care', 'investigatorFullName': 'Huda Fahmy Mahmoud, PhD', 'investigatorAffiliation': 'Aswan University Hospital'}}}}