[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656960":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":39,"studyPopulation":40,"armGroups":41,"interventions":35,"overallOfficials":45,"centralContacts":50,"locations":35,"responsibleParty":56,"collaborators":35,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":35,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":35,"studyType":73,"phases":35,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":83,"whyStopped":35,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":35},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Sepsis Associated Liver Injury Among Pediatric Sepsis Patients","Proportion of children with sepsis who develop SALI defined as total bilirubin greater than or equal to 4.0 mg per dL or ALT greater than 2 times age-specific upper limit of normal during hospitalization. Calculated as number of SALI cases divided by total number of enrolled sepsis patients","30 days after hospital admission",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"All-Cause Mortality in Children With and Without SALI","Number of participants who die from any cause during hospital stay comparing SALI group versus non-SALI group. Mortality includes 28-day and in-hospital mortality",{"measure":18,"description":19,"timeFrame":12},"Frequency of PICU Admission","Number of participants requiring admission to pediatric intensive care unit PICU among SALI and non-SALI groups",{"measure":21,"description":22,"timeFrame":12},"Duration of PICU Stay","Length of PICU stay measured in days from PICU admission to PICU discharge or death among those admitted to PICU",{"measure":24,"description":25,"timeFrame":12},"Hospital Length of Stay","Total duration of hospital stay measured in days from hospital admission to discharge or death",{"measure":27,"description":28,"timeFrame":12},"Need for Mechanical Ventilation","Number of participants requiring invasive mechanical ventilation during hospitalization in SALI versus non-SALI groups",{"measure":30,"description":31,"timeFrame":12},"Need for Vasopressor Therapy","Number of participants requiring vasopressor or inotropic support for septic shock management",{"measure":33,"description":34,"timeFrame":12},"Incidence of Acute Kidney Injury and MODS","Number of participants developing acute kidney injury AKI and multiple organ dysfunction syndrome MODS during hospitalization according to standard criteria",null,{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":37,"timePerspective":38,"maskingInfo":35},"COHORT","PROSPECTIVE","Sepsis-associated liver injury (SALI) is associated with poor prognosis in children with sepsis. This observational study will include children aged 1 month to 18 years diagnosed with sepsis according to the Phoenix Sepsis Score (≥2 points).\n\nPatients will be monitored for the development of SALI, defined as ALT ≥2 times the age-specific upper limit of normal and\u002For total bilirubin \\>2 mg\u002FdL in the absence of another identifiable cause of liver injury. Clinical outcomes including mortality, PICU admission, length of stay, and need for organ support will be recorded.","Children aged 1 month to 18 years admitted to Assiut University Children's Hospital with a diagnosis of sepsis according to the Phoenix Sepsis Score.",[42],{"label":43,"type":35,"description":44,"interventionNames":35},"Single cohort: Children with sepsis","Children aged 1 month to 18 years with sepsis according to the Phoenix Sepsis Score who will be monitored for the development of sepsis-associated liver injury and followed for clinical outcomes.",[46],{"name":47,"affiliation":48,"role":49},"Nagla H Ibrahim, prof","pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[51],{"name":52,"role":53,"phone":54,"phoneExt":35,"email":55},"Ahmed o Ahmed, Resident","CONTACT","01024907722","Ahmed.18313432@med.aun.edu.eg",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Ahmed Osama Ahmed Abd Alhakim","Resident Physician","100656960","sepsis-associated-liver-injury-in-pediatric-sepsis-at-assiut-university-childrens-hospital---2026-100656960",false,"NCT07832890","Sepsis Associated Liver Injury in Pediatric Sepsis at Assiut University Children's Hospital - 2026","Sepsis Associated Liver Injury in Pediatric Patients at Assiut University Children's Hospital: Incidence, Predictors and Clinical Outcomes","Inclusion Criteria:\n\n* Age from 1 month to 18 years\n* Sepsis diagnosed according to the Phoenix Sepsis Score (≥2 points)\n* Written informed consent from parents or legal guardians\n\nExclusion Criteria:\n\n* Neonates less than 28 days of age\n* Pre-existing chronic liver disease (cirrhosis, biliary atresia, metabolic liver diseases, autoimmune hepatitis, acute viral hepatitis, previous liver transplantation, malignancy with hepatic involvement, or drug-induced liver injury present before admission)","ALL","1 Month","18 Years",{"count":71,"type":72},158,"ESTIMATED","OBSERVATIONAL","This prospective cohort study aims to determine the incidence of sepsis-associated liver injury (SALI) among pediatric patients with sepsis admitted to Assiut University Children's Hospital and to evaluate its association with clinical outcomes.",[76,77],"Sepsis","Liver Injury",[76,79,80,81,82],"Liver injury","Pediatric","Phoenix Sepsis Score","Assiut","NOT_YET_RECRUITING","2026-09-16",{"date":86,"type":87},"2026-09-22","ACTUAL",{"date":89,"type":72},"2026-09-20",{"date":91,"type":72},"2028-02-10",{"name":5,"class":6}]