[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647238":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":58,"collaborators":20,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":87,"whyStopped":20,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Menoufia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group (plasma exchange Arm)","ACTIVE_COMPARATOR","this arm will receive standard sepsis management plus therapeutic plasma exchange.",[13],"Procedure: Plasma exchange (PE)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Plasma exchange (PE)","Therapeutic plasma exchange to the intervention Group (plasma exchange Arm) that will receive also the standard sepsis management.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Hani Hamed Saad, MD, pediatrics","Faculty of medicine, Menoufia University","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Hani Hamed Saad, MD, Pediatrics","CONTACT","+201067610619","hani.hamed870@med.menofia.edu.eg",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Nagwan Yossery Saleh, MD, Pediatrics","+201003961071","drnagwan80@gmail.com",[37],{"facility":38,"status":20,"city":39,"state":40,"zip":20,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Menoufia university hospital, Pediatric intensive care unit","Shibīn al Kawm","Menoufia Governorate","Egypt","EG",{"type":44,"coordinates":45},"Point",[46,47],31.00904,30.55258,{"lat":47,"lon":46},[50,51,53,54,56],{"name":23,"role":29,"phone":30,"phoneExt":20,"email":31},{"name":52,"role":29,"phone":34,"phoneExt":20,"email":35},"Nagwan Yossery Saleh, MD, pediatrics",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":52,"role":55,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"name":57,"role":55,"phone":20,"phoneExt":20,"email":20},"Amira Zaki Badawy, MD, clinical pathology",{"type":25,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Hani Hamed Saad","Lecturer of pediatrics at Faculty of medicine , Menoufia university","100647238","plasma-exchange-in-children-with-severe-sepsis-and-septic-shock-100647238",false,"NCT07706413","Plasma Exchange in Children With Severe Sepsis and Septic Shock","Therapeutic Plasma Exchange in Children With Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial","PE\u002FSepsis","Inclusion Criteria:\n\n1. From one month to 18 years.\n2. With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.\n\nExclusion Criteria:\n\n1. Known congenital bleeding disorders and severe uncontrolled hemorrhage.\n2. End-stage chronic illness with expected survival \\\u003C 3 months.\n3. Previous plasma exchange during the same admission.\n4. Contraindications to central venous catheterization.","ALL","1 Month","18 Years",{"count":73,"type":74},22,"ESTIMATED","INTERVENTIONAL",[77],"NA","The aim of the study will be to to evaluate whether therapeutic plasma exchange (TPE) reduces mortality in critically ill children with severe sepsis or septic shock compared to the standard care of sepsis alone.\n\nThe study population will be divided into two groups, the first group will receive standard sepsis management plus therapeutic plasma exchange and the second one will receive the standard sepsis management alone . Then we will assess the effect of TPE on : Severity of organ dysfunction (pSOFA score) , duration of vasopressor support , length of PICU stay, time to hemodynamic stabilization , and on inflammatory and coagulation biomarkers",[80],"Severe Sepsis",[82,83,84,85,86],"Plasma exchange","severe sepsis","septic shock","childern","Randomized controlled trial","NOT_YET_RECRUITING","2026-07-13",{"date":90,"type":91},"2026-07-15","ACTUAL",{"date":93,"type":74},"2026-08-01",{"date":95,"type":74},"2027-03-31",{"name":5,"class":6},1]