[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564940":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":39,"locations":10,"responsibleParty":45,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":10},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Urapidil Group",null,"Urapidil Injection (Shijiazhuang Sipharm Co., Ltd., National Medical Products Administration Approval No. H20233626): Initially, administer a loading dose of 10mg via slow intravenous injection, observe for 5 minutes, and then adjust the infusion rate based on the patient's blood pressure, generally not exceeding 2mg\u002Fmin.",[13],"Drug: Urapidil",{"label":15,"type":10,"description":16,"interventionNames":17},"Combination Group of Urapidil and Esmolol","Urapidil Injection (Shijiazhuang Sipharm Co., Ltd., National Medical Products Administration Approval No. H20233626): Initially, administer a loading dose of 10mg via slow intravenous injection, observe for 5 minutes, and then adjust the infusion rate based on the patient's blood pressure, generally not exceeding 2mg\u002Fmin.\n\nEsmolol Injection (Qilu Pharmaceutical Co., Ltd., National Medical Products Administration Approval No. H19991058): Administer an intravenous bolus of 1mg\u002Fkg within 30 seconds, followed by a maintenance infusion rate not exceeding 300μg\u002Fkg\u002Fmin, adjusted according to blood pressure readings.",[18],"Drug: Urapidil and Esmolol",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Urapidil","1. Control systolic blood pressure within 130-140mmHg using urapidil and maintain this level for 7 days;\n2. Reduce intracranial pressure through dehydration therapy with mannitol, positioning of the body, and other means to prevent cerebral hernia. Surgical interventions such as decompressive craniectomy may be performed if necessary;\n3. Aim for a body temperature control target of ≤37.5°C;\n4. The anticoagulation reversal target is INR \\\u003C 1.5, with correction methods including the use of vitamin K, prothrombin complex concentrate (PCC), or fresh frozen plasma (FFP);\n5. The blood glucose control targets are 6.1-7.8mmol\u002FL for non-diabetic study participants and 7.8-10.0mmol\u002FL for diabetic study participants.",[9],[26],"Ebrantil(34661-75-1)",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Urapidil and Esmolol","1. Utilize both urapidil and esmolol to control systolic blood pressure within 130-140mmHg and maintain this level for 7 days;\n2. Reduce intracranial pressure through dehydration therapy with mannitol, strategic positioning of the body, and other measures to prevent cerebral hernia. Surgical interventions such as decompressive craniectomy may be performed if necessary;\n3. Aim for a body temperature control target of ≤37.5°C;\n4. The anticoagulation reversal target is INR \\\u003C 1.5, with correction methods including the administration of vitamin K, prothrombin complex concentrate (PCC), or fresh frozen plasma (FFP);\n5. The blood glucose control targets are 6.1-7.8mmol\u002FL for non-diabetic study participants and 7.8-10.0mmol\u002FL for diabetic study participants.",[15],[32],"34661-75-1 and 81147-92-4",[34,37],{"name":35,"affiliation":5,"role":36},"Jianjun Wang, Ph.D.","STUDY_DIRECTOR",{"name":38,"affiliation":5,"role":36},"Xueyan Cui, Ph.D.",[40],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Shaofeng Yan, postdoc","CONTACT","15662793799","2415@sdhospital.com.cn",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Jianjun Wang","chief physician","100564940","efficacy-and-safety-study-of-urapidil-alone-or-with-esmolol-in-treating-acute-hypertensive-intracerebral-hemorrhage-100564940",false,"NCT06635707","Efficacy and Safety Study of Urapidil Alone or With Esmolol in Treating Acute Hypertensive Intracerebral Hemorrhage","The Study on the Efficacy and Safety of Using Urapidil Alone or in Combination With Esmolol for the Treatment of Acute Hypertensive Intracerebral Hemorrhage: A Prospective, Open-label, Observational, Multicenter Research","Inclusion Criteria:\n\n1. Participants in the study of acute hypertensive intracerebral hemorrhage aged between 18 and 80 years old;\n2. Participants with acute intracerebral hemorrhage (basal ganglia hemorrhage \\\u003C 50ml) confirmed by imaging within 6 hours of onset;\n3. Participants with systolic blood pressure \\> 140mmHg upon admission;\n4. Participants who have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Participants in the cerebral hemorrhage study who decline to have their disease management information collected and used and\u002For refuse to undergo subsequent follow-ups;\n2. Participants with allergies to the medication in question;\n3. Participants in the study of secondary cerebral hemorrhage resulting from tumors, vascular malformations, aneurysms, trauma, post-thrombolytic therapy, or cerebral arteriovenous thrombosis;\n4. Participants undergoing anticoagulant therapy or with coagulation disorders;\n5. Pregnant women;\n6. Participants with multiple organ failure;\n7. Participants deemed unsuitable for enrollment by the research staff due to other factors.","ALL","18 Years","80 Years",{"count":60,"type":61},600,"ESTIMATED","3 Months","OBSERVATIONAL","The objective of this study is to investigate the efficacy and safety of urapidil monotherapy versus the combination of esmolol in treating participants with acute hypertensive intracerebral hemorrhage through a prospective, open-label, observational, multicenter clinical trial, aiming to provide guidance for clinicians in formulating rational treatment plans.",[66],"Hypertensive Intracerebral Hemorrhage","NOT_YET_RECRUITING","2024-10-08",{"date":70,"type":71},"2024-10-10","ACTUAL",{"date":73,"type":61},"2024-11-01",{"date":75,"type":61},"2026-12-01",{"name":5,"class":6}]