[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622398":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":73,"collaborators":31,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":31,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":47,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Northern Jiangsu People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hydrocortisone plus Fludrocortisone","EXPERIMENTAL","Hydrocortisone: 200 mg per day administered by continuous intravenous infusion for up to 7 days or until ICU discharge, whichever occurs first.\n\nFludrocortisone: 50 μg administered orally or via nasogastric tube once daily for up to 7 days or until ICU discharge, whichever occurs first.",[13],"Drug: Hydrocortisone plus Fludrocortisone",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard care","ACTIVE_COMPARATOR","Patients will receive standard care for septic shock according to current international guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures, including the use of hydrocortisone at the discretion of the treating physician, but without fludrocortisone.",[19],"Other: Standard care",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Hydrocortisone will be administered at a dose of 200 mg per day by continuous intravenous infusion.\n\nFludrocortisone will be administered at a dose of 50 μg once daily orally or via nasogastric tube.\n\nBoth drugs will be given for up to 7 days or until ICU discharge, whichever occurs first.",[9],[26,27],"Hydrocortisone Injection","Fludrocortisone Acetate Tablets",{"type":6,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Patients will receive standard care for septic shock according to current international and institutional guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures. Fludrocortisone will not be administered.Hydrocortisone may be administered at the discretion of the treating physician.",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Qingquan Lyu, Master","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},"CONTACT","0086-18051063899","bonhomie2014@163.com",{"name":42,"role":38,"phone":43,"phoneExt":31,"email":44},"Xiaohua Gu, Master","0086-18051062325","njguxiaohua@163.com",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Yangzhou","Jiangsu","225000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],119.43583,32.39722,{"lat":57,"lon":56},[60,61,62,63,65,67,69,71],{"name":34,"role":38,"phone":39,"phoneExt":31,"email":40},{"name":42,"role":38,"phone":43,"phoneExt":31,"email":44},{"name":34,"role":35,"phone":31,"phoneExt":31,"email":31},{"name":42,"role":64,"phone":31,"phoneExt":31,"email":31},"SUB_INVESTIGATOR",{"name":66,"role":64,"phone":31,"phoneExt":31,"email":31},"Ruiqiang Zheng, Bachelor",{"name":68,"role":64,"phone":31,"phoneExt":31,"email":31},"Jiangquan Yu, Doctor",{"name":70,"role":64,"phone":31,"phoneExt":31,"email":31},"Ying Shi, Master",{"name":72,"role":64,"phone":31,"phoneExt":31,"email":31},"Yuanjin Pan, Bachelor",{"type":35,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Qing-quan Lv","Principal Investigator","100622398","phase-4-hydrocortisone-and-fludrocortisone-for-the-treatment-of-septic-shock-100622398",false,"NCT07383103","Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock","Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock：A Prospective Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n(1)18≤Age≤90; (2)Diagnosis of septic shock within 12 h.\n\nExclusion Criteria:\n\nPatients meeting any of the following conditions will be excluded:\n\n1. Systemic corticosteroid therapy within the last 3 months before septic shock;\n2. High-dose steroid therapy;\n3. Immunosuppression;\n4. Pregnant;\n5. Known allergy to hydrocortisone or fludrocortisone;\n6. Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting;\n7. Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);\n8. Refusal of the attending staff or patient family;\n9. Current participation in another clinical trial.","ALL","18 Years","90 Years",{"count":87,"type":88},336,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","The purpose of this study is to evaluate the efficacy and safety of the combination therapy of hydrocortisone and fludrocortisone among adult patients with septic shock.",[94],"Septic Shock",[96,97,98,99],"septic shock","hydrocortisone","fludrocortisone","mortality","2026-03-03",{"date":102,"type":103},"2026-03-04","ACTUAL",{"date":105,"type":103},"2026-03-02",{"date":107,"type":88},"2028-12-31",{"name":5,"class":6},1]