Sepsis Associated Liver Injury in Pediatric Patients at Assiut University Children's Hospital: Incidence, Predictors and Clinical Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 158
- Primary Endpoint
- Incidence of Sepsis Associated Liver Injury Among Pediatric Sepsis Patients
Study Overview
Brief Summary
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.
Detailed Description
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).
Patients will be monitored for the development of SALI, defined as ALT ≥2 times the age-specific upper limit of normal and/or total bilirubin >2 mg/dL 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 1 month to 18 years
- •Sepsis diagnosed according to the Phoenix Sepsis Score (≥2 points)
- •Written informed consent from parents or legal guardians
Exclusion Criteria
- •Neonates less than 28 days of age
- •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)
Arms & Interventions
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.
Outcomes
Primary Outcomes
Incidence of Sepsis Associated Liver Injury Among Pediatric Sepsis Patients
Time Frame: 30 days after hospital admission
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
Secondary Outcomes
- All-Cause Mortality in Children With and Without SALI(30 days after hospital admission)
- Frequency of PICU Admission(30 days after hospital admission)
- Duration of PICU Stay(30 days after hospital admission)
- Hospital Length of Stay(30 days after hospital admission)
- Need for Mechanical Ventilation(30 days after hospital admission)
- Need for Vasopressor Therapy(30 days after hospital admission)
- Incidence of Acute Kidney Injury and MODS(30 days after hospital admission)
Investigators
Ahmed Osama Ahmed Abd Alhakim
Resident Physician
Assiut University