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NCT Number: NCT07832890

Sepsis Associated Liver Injury in Pediatric Sepsis at Assiut University Children's Hospital - 2026

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.

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Key information

Conditions

Sepsis Infections Inflammation Liver Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  1. All-Cause Mortality in Children With and Without SALI

    Time frame: 30 days after hospital admission

    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

  2. Frequency of PICU Admission

    Time frame: 30 days after hospital admission

    Number of participants requiring admission to pediatric intensive care unit PICU among SALI and non-SALI groups

  3. Duration of PICU Stay

    Time frame: 30 days after hospital admission

    Length of PICU stay measured in days from PICU admission to PICU discharge or death among those admitted to PICU

  4. Hospital Length of Stay

    Time frame: 30 days after hospital admission

    Total duration of hospital stay measured in days from hospital admission to discharge or death

  5. Need for Mechanical Ventilation

    Time frame: 30 days after hospital admission

    Number of participants requiring invasive mechanical ventilation during hospitalization in SALI versus non-SALI groups

  6. Need for Vasopressor Therapy

    Time frame: 30 days after hospital admission

    Number of participants requiring vasopressor or inotropic support for septic shock management

  7. Incidence of Acute Kidney Injury and MODS

    Time frame: 30 days after hospital admission

    Number of participants developing acute kidney injury AKI and multiple organ dysfunction syndrome MODS during hospitalization according to standard criteria

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Sepsis Associated Liver Injury in Pediatric Patients at Assiut University Children's Hospital: Incidence, Predictors and Clinical Outcomes

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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