[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627688":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":71,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":98,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fludrocortisone","EXPERIMENTAL",null,[13],"Drug: Fludrocortisone 100 mcg daily",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Fludrocortisone 100 mcg daily","Patients will be given enteral fludrocortisone 100 mcg daily for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"Patients will be given an enteral placebo tablet for 7 days or until discharge from ICU or death, whichever comes first. All patients will be treated with 7 days of intravenous hydrocortisone 50 mg every 6 hours for 7 days from randomization or until discharge from ICU or death, whichever comes first.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Lowell Ling, MBBS","CONTACT","(852) 35052735","lowell.ling@cuhk.edu.hk",[35,46,51,61,66],{"facility":36,"status":37,"city":38,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":11},"North District Hospital","NOT_YET_RECRUITING","Hong Kong","HK",{"type":41,"coordinates":42},"Point",[43,44],114.17469,22.27832,{"lat":44,"lon":43},{"facility":47,"status":37,"city":38,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":48,"geoPoint":50,"contacts":11},"Pamela Youde Nethersole Hospital",{"type":41,"coordinates":49},[43,44],{"lat":44,"lon":43},{"facility":52,"status":53,"city":38,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Prince of Wales Hospital","RECRUITING",{"type":41,"coordinates":55},[43,44],{"lat":44,"lon":43},[58],{"name":59,"role":31,"phone":60,"phoneExt":11,"email":33},"Ling Lowell, MBBS","+852 35051311",{"facility":62,"status":37,"city":38,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":63,"geoPoint":65,"contacts":11},"Princess Margaret Hospital",{"type":41,"coordinates":64},[43,44],{"lat":44,"lon":43},{"facility":67,"status":37,"city":38,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":68,"geoPoint":70,"contacts":11},"Queen Mary Hospital",{"type":41,"coordinates":69},[43,44],{"lat":44,"lon":43},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Lowell Ling","Associate Professor","100627688","phase-2-adjunctive-fludrocortisone-in-septic-shock-100627688",false,"NCT07451886","Adjunctive Fludrocortisone in Septic Shock","Adjunctive Fludrocortisone in Septic Shock: a Multicenter, Double-blind, Randomized, Placebo-controlled Pilot Trial (AFLUDROS-1)","AFLUDROS-1","Inclusion Criteria:\n\n1. suspected or confirmed adult sepsis as defined by ≥ 2 increase in Sequential Organ Failure Assessment (SOFA) score due to infection\n2. ≥0.25 μg\u002Fkg\u002Fmin of noradrenaline infusion or vasoactive-inotropic score (VIS) ≥25 to maintain mean arterial pressure (MAP) ≥65 mmHg for at least 1 hour\n3. onset of septic shock within 24 hours\n4. shock due to infection with no other proven or apparent cause\n5. hypoperfusion defined as arterial or venous lactate concentration \\>2.0 mmol\u002FL\n6. mechanical ventilation\n\nExclusion Criteria:\n\n1. fludrocortisone cannot be administered within 24 hours of onset of septic shock\n2. death is deemed imminent or inevitable by treating clinicians\n3. limitation of therapy\n4. an underlying disease process with a life expectancy of less than 90 days\n5. pregnancy (confirmed or suspected)\n6. receiving immunomodulatory agents including hydrocortisone \\> 300mg\u002Fday\n7. enteral medication cannot be administered\n8. prescribed fludrocortisone for other medical condition\n9. contraindication to hydrocortisone or fludrocortisone","ALL","18 Years",{"count":86,"type":87},32,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","Sepsis is a life-threatening condition caused by the body's dysregulated response to an infection. While corticosteroids are known to help stabilize blood pressure in septic shock, their ability to reduce mortality is still debated. Recent analyses suggest that combining fludrocortisone with hydrocortisone may be more effective at saving lives than hydrocortisone alone.\n\nTo test this hypothesis, a large, definitive international trial is needed. However, this research proposal is for a smaller pilot study (Phase II) involving 32 critically ill patients. The primary goal of this pilot is to determine the feasibility of conducting the subsequent large-scale trial that would compare hydrocortisone alone against the combination therapy and potentially change medical practice.",[93,94,95,96,97],"Sepsis","Septic Shock","Sepsis - to Reduce Mortality in the Intensive Care Unit","Sepsis and Septic Shock","Sepsis at Intensive Care Unit",[9,99,93,100,101,102],"Septic shock","hydrocortisone","intensive care unit","pilot","2026-06-01",{"date":105,"type":106},"2026-06-02","ACTUAL",{"date":108,"type":106},"2026-04-01",{"date":110,"type":87},"2028-07-31",{"name":5,"class":6},5]