[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607454":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":84,"collaborators":41,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":41,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Imam Abdulrahman Bin Faisal University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Restricted approach group","EXPERIMENTAL","Patients in this arm will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered",[13],"Drug: Sodium Chloride (NaCl) 0.9 %",{"label":15,"type":16,"description":17,"interventionNames":18},"Liberal Approach Group","ACTIVE_COMPARATOR","Patients will receive an IV bolus of 20 mL\u002Fkg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml\u002Fkg times the calculated daily maintenance requirements",[13],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sodium Chloride (NaCl) 0.9 %","Keep vein open rate",[9],[26],"Restricted",{"type":21,"name":22,"description":28,"armGroupLabels":29,"otherNames":30},"IV bolus of 20 mL\u002Fkg of normal saline over 1 hour, followed by maintenance fluids at 1.5-2 ml\u002Fkg times the calculated daily maintenance requirements",[15],[31],"Liberal",[33],{"name":34,"affiliation":35,"role":36},"Mohammed S Alshahrani, MD","King Fahd Hospital of the University- Imam Abdulrahman Bin Faisal University","PRINCIPAL_INVESTIGATOR",[38,43],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+966556966663",null,"msshahrani@iau.edu.sa",{"name":44,"role":39,"phone":41,"phoneExt":41,"email":45},"Laila Perlas Asonto, RN","lasonto@iau.edu.sa",[47,71],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"King Fahd Hospital of the University","RECRUITING","Dammam","Eastern Province","31952","Saudi Arabia","SA",{"type":56,"coordinates":57},"Point",[58,59],50.10326,26.43442,{"lat":59,"lon":58},[62,63,66,67,70],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":64,"role":39,"phone":65,"phoneExt":41,"email":45},"Laila P Asonto, RN","+966554586033",{"name":34,"role":36,"phone":41,"phoneExt":41,"email":41},{"name":68,"role":69,"phone":41,"phoneExt":41,"email":41},"Khalid Alamer, MD","SUB_INVESTIGATOR",{"name":64,"role":69,"phone":41,"phoneExt":41,"email":41},{"facility":72,"status":49,"city":73,"state":41,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"King Saud University Medical City","Riyadh",{"type":56,"coordinates":75},[76,77],46.72185,24.68773,{"lat":77,"lon":76},[80],{"name":81,"role":39,"phone":82,"phoneExt":41,"email":83},"Hassan Alshaqaq, MD","966544509443","hassan.m.alshaqaq@gmail.com",{"type":36,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Mohammed Saeed Saad Alshahrani","Consultant, Emergency and Critical Care Departments","100607454","efficacy-of-liberal-versus-restricted-iv-fluid-approach-in-the-management-of-sickle-cell-vaso-occlusive-crisis-100607454",false,"NCT07188766","Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis","Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)","FLASC","Inclusion Criteria:\n\n1. Patients \\>18 years old with a confirmed diagnosis of SCD.\n2. Presenting with a VOC.\n3. NPRS \\>5\n4. Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n1. Patient requiring specialized IVF management as per the treating physician discretion.\n2. Patients with congestive heart failure, and \u002For acute or chronic symptomatic systolic heart failure\n3. Patients with ESRD on chronic dialysis\n4. Patients with signs of shock (low SBP \\\u003C100 or MAP \\\u003C 65) and signs of hypo perfusion\n5. Known or suspected pregnancy\n6. Previously enrolled in this trial within the last 30 days\n7. Enrolled in another trial study that interfered with fluid management\n8. Unable to obtain IV access.","ALL","18 Years","60 Years",{"count":99,"type":100},394,"ESTIMATED","INTERVENTIONAL",[103],"NA","Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. This study evaluates restrictive versus liberal fluid management strategies in patients with acute VOC.\n\nThis multi-center, open-label, non-inferiority RCT will enroll patients with SCD presenting with acute VOC. Participants will be randomized to either a restrictive or liberal intravenous fluid management protocol. Primary outcome is pain score reduction. Secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid dose, adverse events (incidence of fluid overload, pulmonary congestion), acute chest syndrome, incidence of acute kidney injury, revisit rates within 72 hours of ED discharge, need for intensive care or high-dependency unit admission, need for additional interventions, and 28 days overall mortality. Data will be analyzed using intention-to-treat principles.\n\nWe hypothesize that a restrictive fluid strategy will achieve non-inferior pain control compared to a liberal strategy, while minimizing fluid-related complications. This study will provide evidence to inform clinical guidelines for fluid management in SCD patients experiencing VOCs.",[106,107],"SCD","Vaso Occlussive Crisis",[109,110,111,112],"sickle cell disease","sickle cell crisis","intravenous fluid","emergency department","2026-03-16",{"date":115,"type":116},"2026-03-18","ACTUAL",{"date":118,"type":116},"2025-10-05",{"date":120,"type":100},"2028-10",{"name":5,"class":6},2]