SepsisNCT07832890
Sepsis Associated Liver Injury in Pediatric Sepsis at Assiut University Children's Hospital - 2026
An observational study of Sepsis and Liver Injury, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Sepsis, Liver Injury
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 10 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sepsis Associated Liver Injury in Pediatric Patients at Assiut University Children's Hospital: Incidence, Predictors and Clinical Outcomes
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.
Read the 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.
- Conditions
- Sepsis, Liver Injury
- Keywords
- Sepsis, Liver injury, Pediatric, Phoenix Sepsis Score, Assiut
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after hospital admission
Secondary outcomes (7)
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
Measured: 30 days after hospital admission
Frequency of PICU Admission
Number of participants requiring admission to pediatric intensive care unit PICU among SALI and non-SALI groups
Measured: 30 days after hospital admission
Duration of PICU Stay
Length of PICU stay measured in days from PICU admission to PICU discharge or death among those admitted to PICU
Measured: 30 days after hospital admission
Hospital Length of Stay
Total duration of hospital stay measured in days from hospital admission to discharge or death
Measured: 30 days after hospital admission
Need for Mechanical Ventilation
Number of participants requiring invasive mechanical ventilation during hospitalization in SALI versus non-SALI groups
Measured: 30 days after hospital admission
Need for Vasopressor Therapy
Number of participants requiring vasopressor or inotropic support for septic shock management
Measured: 30 days after hospital admission
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
Measured: 30 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Osama Ahmed Abd Alhakim, Assiut University
- Investigators
- Nagla H Ibrahim, prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832890
- Sponsor's protocol ID
- SALI-Peds-Assiut-2026-30
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis Associated Liver Injury in Pediatric Patients at Assiut University Children's Hospital: Incidence, Predictors and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07832890
- Acronym / sponsor ID
- SALI-Peds-Assiut-2026-30
- Conditions
- Sepsis, Liver Injury
- Keywords
- Sepsis, Liver injury, Pediatric, Phoenix Sepsis Score, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
All-Cause Mortality in Children With and Without SALI
Time frame: 30 days after hospital admission
Frequency of PICU Admission
Time frame: 30 days after hospital admission
Duration of PICU Stay
Time frame: 30 days after hospital admission
Hospital Length of Stay
Time frame: 30 days after hospital admission
Need for Mechanical Ventilation
Time frame: 30 days after hospital admission
Need for Vasopressor Therapy
Time frame: 30 days after hospital admission
Incidence of Acute Kidney Injury and MODS
Time frame: 30 days after hospital admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nagla H Ibrahim, prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Liver Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed o Ahmed, Resident (01024907722, Ahmed.18313432@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Sepsis Associated Liver Injury Among Pediatric Sepsis Patients (time frame: 30 days after hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.