[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651549":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":39,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":25,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group (A): Will receive intravenous magnesium sulfate MgSO₄.","EXPERIMENTAL","32 patients will receive\n\n* Loading Dose: Administered within 8 hours of trauma at a dose of 50 mg\u002Fkg via IV infusion over 1 hour.\n* Maintenance Dose: Administered at 25 mg\u002Fkg every 12 hours (twice daily) for 48 hours.",[13],"Drug: Magnesium sulfate (MgSO4)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group (B): Will receive intravenous normal saline as a placebo.","32 patients Will receive intravenous normal saline as a placebo.",[18],"Drug: Normal Saline",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Magnesium sulfate (MgSO4)","evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI)",[9],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Normal Saline",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Ehab Samir, Assistant lecturer","CONTACT","+201003078676","hobasamir12@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Ghada Abolfadl, Prof.","+201005802086","ghadafadl@aun.edu.eg",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ehab William Samir","Principal Investigator","100651549","phase-4-anti-inflammatory-effect-of-mgso-in-patients-with-moderate-traumatic-brain-injury-by-measurming-nucleotide-binding-oligomerization-domain-like-receptor-pyrin-domain-containing-3-nlrp3-inflammasome-a-multiprotein-complex-100651549",false,"NCT07763665","Anti-inflammatory Effect of MgSO₄ in Patients With Moderate Traumatic Brain Injury by Measurming Nucleotide-binding Oligomerization Domain-Like Receptor Pyrin Domain-containing 3 (NLRP3) Inflammasome-a Multiprotein Complex","Anti-Inflammatory Effect of Magnesium Sulfate on the Outcomes of Patients With Moderate Traumatic Brain Injury.","Inclusion Criteria:\n\n1. Male and female patients aged 18 to 60 years.\n2. Sustained a closed head trauma with the study drug infusion initiated within 8 hours of the injury.\n3. TBI confirmed by history and clinical examination.\n4. Patients with moderate (GCS = 9-12) traumatic brain injury.\n5. Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification ).\n6. Hemodynamic stability at the time of enrollment.\n\nExclusion Criteria:\n\n1. Patient Refusal\n2. Prolonged and\u002For uncorrectable hypoxia (PaO₂ \\\u003C 60 mmHg) or persistent hypotension (systolic blood pressure \\\u003C 90 mmHg) at the time of randomization.\n3. Cardiopulmonary arrest.\n4. Concomitant spinal cord injury.\n5. Pregnant or lactating females.\n6. Penetrating head injury.\n7. Associated other extra-cranial trauma or systemic polytrauma.\n8. Undergoing surgical interventions during the study.\n9. Pre-existing severe cardiac arrhythmia, heart block, or significant myocardial damage (documented on ECG).\n10. Known history of chronic renal failure or abnormal baseline renal function.\n11. Known hypersensitivity or allergic reaction to magnesium sulfate.\n12. Patients on chronic steroid therapy.\n13. BMI\\>35 kg\u002Fm2.\n\n    \\-","ALL","18 Years","60 Years",{"count":54,"type":55},64,"ESTIMATED","INTERVENTIONAL",[58],"PHASE4","The primary objective of this study is to evaluate the biochemical efficacy of Magnesium Sulfate (MgSO₄) as an anti-inflammatory therapeutic agent in patients suffering from moderate traumatic brain injury (TBI) at Assiut University Hospitals by measuring Nucleotide-binding oligomerization domain-Like Receptor Pyrin domain-containing 3 (NLRP3) inflammasome-a multiprotein complex.",[61],"Traumatic Brain Injuries",[63],"anti-inflammatory effect of magnesium sulfate","NOT_YET_RECRUITING","2026-08-10",{"date":67,"type":68},"2026-08-13","ACTUAL",{"date":70,"type":55},"2026-10-01",{"date":72,"type":55},"2028-01-01",{"name":5,"class":6}]