Acute Liver FailureNCT06893042
Clinical Study of Pediatric Acute Liver Failure
An observational study of Acute Liver Failure, run by Fansen Zeng at 1 site in China.
Trial summary
The goal of this observational study is to understand the etiology, prognosis and influencing factors of acute liver failure in children, evaluate the predictive value of children's SOFA score, PELD score and LIU score for the short-term mortality rate of children's liver failure and the infection of children's acute… Read more about this study
- Who is it for?
- Ages 1 minute to 18 years
- Conditions the study is for
- Acute Liver Failure
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Aug 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 minute to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The children under the age of 18 diagnosed with acute liver failure in Guangzhou Women's and Children's Medical Center.
Who may be able to join
- （1) The age is less than 18 years old; (2) Acute onset (≤8 weeks), no liver disease basis in the past; (3) Biochemical evidence of severe liver injury ; (4) Coagulation dysfunction that cannot be corrected by vitamin K: prothrombin time (PT) ≥15s or international standardized ratio (INR) ≥1.5, and accompanied by hepatic encephalopathy at the same time; or meet any of PT≥20s, INR≥2.0, may not be accompanied by hepatic encephalopathy; (5) Provide complete clinical data and treatment records. (6) Agree to participate in this study and obtain informed consent.
- Exclusion Criteria:(1) Multiple organ failure caused by non-hepatic diseases; (2) Missing data or incomplete follow-up information.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women's and Children's Medical Center
Guangzhou, Guangdong, 510000
About this study
Official title: A Prospective Study on the Real Word of Acute Liver Failure in Children
The goal of this observational study is to understand the etiology, prognosis and influencing factors of acute liver failure in children, evaluate the predictive value of children's SOFA score, PELD score and LIU score for the short-term mortality rate of children's liver failure and the infection of children's acute liver failure; analyze the bleeding and kidney damage of children's acute liver failure, and evaluate the quality of life of children's acute liver failure.
Read the detailed description
PALF is a seriously life-threatening acute disease with a rapid onset, rapid progression and high mortality rate. Especially under the influence of multiple organ dysfunction syndrome (MODS) or other serious complications, clinical prognosis evaluation and treatment decision-making face great challenges.It aims to accurately evaluate the survival probability or liver transplantation needs of patients based on clinical data and biological indicators, and deeply reveal the impact of different factors on the prognosis of PALF from the perspective of etiology, treatment mode (such as mechanical ventilation and plasma replacement) and complications (such as MODS and its score), so as to provide a scientific basis for identifying high-risk groups, optimizing personalized treatment strategies and early diagnosis.
- Conditions
- Acute Liver Failure
- Medical subject headings
- Liver Failure, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
With the changes of various indicators such as blood ammonia albumin lactic acid coagulation function with the implementation of treatment
All are specific numerical measurements.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Sep 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- 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
- 7 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fansen Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fansen Zeng, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893042
- Sponsor's protocol ID
- 346A01
- Status last verified
- Aug 2024
- First submitted
- 18 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Real Word of Acute Liver Failure in Children
- ClinicalTrials.gov ID
- NCT06893042
- Acronym / sponsor ID
- 346A01
- Conditions
- Acute Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Fansen ZengUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Mar 2025 (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.
The goal of this observational study is to understand the etiology, prognosis and influencing factors of acute liver failure in children, evaluate the predictive value of children's SOFA score, PELD score and LIU score for the short-term mortality rate of children's liver failure and the infection of children's acute liver failure; analyze the bleeding and kidney damage of children's acute liver failure, and evaluate the quality of life of children's acute liver failure.
Detailed description
PALF is a seriously life-threatening acute disease with a rapid onset, rapid progression and high mortality rate. Especially under the influence of multiple organ dysfunction syndrome (MODS) or other serious complications, clinical prognosis evaluation and treatment decision-making face great challenges.It aims to accurately evaluate the survival probability or liver transplantation needs of patients based on clinical data and biological indicators, and deeply reveal the impact of different factors on the prognosis of PALF from the perspective of etiology, treatment mode (such as mechanical ventilation and plasma replacement) and complications (such as MODS and its score), so as to provide a scientific basis for identifying high-risk groups, optimizing personalized treatment strategies and early diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 1 minute to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The children under the age of 18 diagnosed with acute liver failure in Guangzhou Women's and Children's Medical Center.
Key inclusion criteria (3 listed)
- （1) The age is less than 18 years old; (2) Acute onset (≤8 weeks), no liver disease basis in the past; (3) Biochemical evidence of severe liver injury ; (4) Coagulation dysfunction that cannot be corrected by vitamin K: prothrombin time (PT) ≥15s or international standardized ratio (INR) ≥1.5, and accompanied by hepatic encephalopathy at the same time; or meet any of PT≥20s, INR≥2.0, may not be accompanied by hepatic encephalopathy; (5) Provide complete clinical data and treatment records. (6) Agree to participate in this study and obtain informed consent.
- Exclusion Criteria:(1) Multiple organ failure caused by non-hepatic diseases; (2) Missing data or incomplete follow-up information.
- -
Key exclusion criteria (0 listed)
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
With the changes of various indicators such as blood ammonia albumin lactic acid coagulation function with the implementation of treatment
Time frame: From enrollment to the end of treatment at 6 months
All are specific numerical measurements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Acute Liver Failure
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Acute-on-Chronic Liver Failure (ACLF)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure, run by Fansen Zeng at 1 site in China.
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 0 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: status not confirmed, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
With the changes of various indicators such as blood ammonia albumin lactic acid coagulation function with the implementation of treatment (time frame: From enrollment to the end of treatment at 6 months). 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 25 Mar 2025.