Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT04408768
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2020-05-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Hyperglycemia and Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': '30 days', 'description': 'The NIHSS score categorized into: no stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42)'}], 'secondaryOutcomes': [{'measure': '30-days mortality', 'timeFrame': '30 days', 'description': 'Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.', 'detailedDescription': 'Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases.\n\nThe NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study included eighty acute ischemic stroke patients who presented within 24 hours of onset of symptoms. They were equally divided into two groups; group A included patients with normal (70-150 mg/dl) RBS on ICU admission and controlled blood sugar within 24 h, while group B included those with high RBS on ICU admission and uncontrolled blood sugar during first 24 h.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ischemic stroke within 24 hours of onset of symptoms\n\nExclusion Criteria:\n\n* subdural hematoma\n* Transient ischemic attack\n* Subarachnoid hemorrhage\n* Hemorrhagic stroke\n* Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar (RBS) \\< 150 mg/dl) within 24 hours with insulin therapy, diabetic\n* Ketoacidosis\n* RBS less than 70 mg/dl on admission'}, 'identificationModule': {'nctId': 'NCT04408768', 'briefTitle': 'Stress Hyperglycemia and Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients', 'orgStudyIdInfo': {'id': 'El Zaiton Specialized Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal RBS', 'description': 'Normal RBS on ICU admission and controlled blood sugar within 24 hours', 'interventionNames': ['Other: standard protocol for stroke patients']}, {'label': 'High RBS', 'description': 'High RBS on ICU admission and uncontrolled blood sugar during first 24 hours', 'interventionNames': ['Other: standard protocol for stroke patients']}], 'interventions': [{'name': 'standard protocol for stroke patients', 'type': 'OTHER', 'otherNames': ['no specific intervention'], 'description': 'Standard protocol for stroke patients', 'armGroupLabels': ['High RBS', 'Normal RBS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Ain Shams University Specialized Hospital', 'country': 'Egypt', 'facility': 'Hanaa El Gendy', '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': 'Hanaa Mohamed Abdallah ElGendy MD', 'investigatorAffiliation': 'Ain Shams University'}}}}