Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT04412850
Status:
UNKNOWN
Last Update Posted:
2020-06-02
First Post:
2020-05-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Magnesium Sulphate in Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-01', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'adverse effects', 'timeFrame': '7 days'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH Stroke Scale (NIHSS) in patients with acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with a confirmed diagnosis of ischemic stroke on neurological examination and CT scan findings aged between 45 -95 years of age of either gender.\n* Adults presenting within a stroke onset of 24 hours.\n\nExclusion Criteria:\n\n* Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial bleed or space occupying lesion)\n\n * Subjects with systolic blood pressure less than 90mmHg\n * Presence of Bundle Branch block or atrioventricular block.\n * Serum Creatinine \\> 3mg/dl\n * Respiratory failure (O2 saturation \\<90% or Respiratory Rate \\>24 or \\<12)\n * Pregnancy.'}, 'identificationModule': {'nctId': 'NCT04412850', 'briefTitle': 'Intravenous Magnesium Sulphate in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Role of Intravenous Magnesium Sulphate in Improving Clinical Outcome in Patients Suffering From Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'huda01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect.', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'Normal Saline in equal volume as the control group.', 'interventionNames': ['Drug: Magnesium Sulfate']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'Magnesium and placebo (Normal Saline) will be prepared as solutions of identical volume and appearance. All patients will be randomized and blind to treatment.\n\nAll patients will have pretreatment Electrogram (ECG), serum biochemistry and serum Magnesium levels. Serum Magnesium levels will also be measured at 48 hours. Blood pressure, heart rate, respiratory rate and serious adverse events will be monitored at baseline, 15 minutes, and 12, 24 and 48 hours after infusion. Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form.\n\nFollow-up visits will be conducted by the same investigators, and repeated scores on the NIH Stroke Scale will be obtained at 24 hours, 48 hours post admission and on the day of discharge.', 'armGroupLabels': ['Control group', 'placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Huda Naim, MBBS', 'role': 'CONTACT', 'email': 'huda_naim@live.com', 'phone': '03333656270'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Huda Naim', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}