Sepsis Associated Liver Injury in Pediatric Sepsis at Assiut University Children's Hospital - 2026
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
158 Participants
are grouped into 1 trial groupGroup A: Single cohort: Children with sepsis
Trial outcomes
Primary outcomes
1
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
Time frame
30 days after hospital admissionSecondary outcomes
1
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
Time frame
30 days after hospital admission2
Frequency of PICU Admission
Number of participants requiring admission to pediatric intensive care unit PICU among SALI and non-SALI groups
Time frame
30 days after hospital admission3
Duration of PICU Stay
Length of PICU stay measured in days from PICU admission to PICU discharge or death among those admitted to PICU
Time frame
30 days after hospital admission4
Hospital Length of Stay
Total duration of hospital stay measured in days from hospital admission to discharge or death
Time frame
30 days after hospital admissionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: