Acute Liver FailureEPOCH-ALFNCT06778941
Etiology and Prognostic Analysis of Acute Liver Failure in Chinese Children
An observational study of Acute Liver Failure, run by liyumei.
Trial summary
Research Background: Pediatric acute liver failure (PALF) refers to the sudden onset of severe liver injury in children without known chronic liver disease, leading to multi-system organ dysfunction, with a mortality rate as high as 50%-70%. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Acute Liver Failure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Jun 2029
- 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Criteria for Diagnosing Pediatric Acute Liver Failure
Who may be able to join
- According to the diagnostic criteria for PALF, the following conditions must be met:
- ① Severe biochemical liver abnormalities occurring within 8 weeks;
- ② Coagulation disorders uncorrectable by vitamin K: if hepatic encephalopathy is present, prothrombin time (PT) > 15s or international normalized ratio (INR) > 1.5; regardless of the presence of hepatic encephalopathy, PT > 20s or INR > 2.0.
- For patients who were admitted twice, only the information from the first hospitalization will be used.
- Patients with a history of chronic liver disease (e.g., genetic metabolic factors, drug-induced factors) or biliary obstruction that led to the acute episode are categorized under acute liver failure.
- The child's legal guardian has signed a written informed consent form.
Who cannot join
- Age > 18 years;
- Significant data missing (>10%);
- The child's legal guardian refuses participation.
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: Etiology and Prognostic Analysis of Acute Liver Failure in Chinese Children: a Multi-center Bidirectional Observational Cohort Study
Research Background:
Pediatric acute liver failure (PALF) refers to the sudden onset of severe liver injury in children without known chronic liver disease, leading to multi-system organ dysfunction, with a mortality rate as high as 50%-70%. The etiology of PALF is complex and varied, including infections, metabolic disorders, and toxins. In developed countries, it is often caused by drug and toxin exposure, while in developing countries, viral infections are the primary cause. Additionally, 30%-50% of PALF cases have an unknown etiology, which increases the difficulty of treatment. Current treatment options include medical management, artificial liver support, and liver transplantation. Liver transplantation is the only proven effective treatment, but issues such as organ shortages and the timing of transplantation affect treatment outcomes. Improving diagnostic capabilities for the etiology and exploring optimal treatment strategies are of significant importance in enhancing the clinical success rate of PALF management.
Read more
Research Objective:
To explore the etiology and prognostic factors of pediatric acute liver failure (PALF), analyze the relationship between different causes of PALF and prognosis, and the relationship between different treatment modalities and prognosis. This study aims to investigate the correlation between etiology, treatment methods, and outcomes, providing scientific evidence to improve the precision in diagnosis and treatment of PALF and to enhance decision-making and timing judgments for liver transplantation.
Read the detailed description
Data were organized and analyzed using WindRays statistical software. Quantitative data that followed a normal distribution were expressed as mean ± standard deviation (x ± s), and intergroup comparisons were performed using t-tests. For non-normally distributed quantitative data, median (interquartile range) [M (P25, P75)] was used, and intergroup comparisons were conducted using the Mann-Whitney U test. Qualitative data were presented as frequencies (n) and percentages (%), with intergroup comparisons made using χ² or Fisher's exact test. Multivariate logistic and Cox regression analyses were performed to adjust for potential confounding factors in the association between PALF etiology, treatment, and prognosis. Results were presented as odds ratios (ORs) with 95% confidence intervals (CIs). A multivariate-adjusted restricted cubic spline model was constructed to examine possible non-linear dose-response relationships between PALF etiology, treatment, and prognosis. Variables were selected using stepwise regression, lasso regression, and best subset regression. Risk scoring models were established using regression analysis, nomograms, scoring systems, decision trees, and machine learning algorithms. Sensitivity analyses were conducted using propensity score matching (PSM), regression analysis, and stratified analysis. The predictive efficacy of the model for PALF prognosis was evaluated using the area under the receiver operating characteristic (ROC) curve (AUC), with AUC ≥ 0.80 indicating good predictive value. Data with missing values less than 5% were deleted directly, and data with missing values between 5% and 20% were imputed using multiple imputation methods.
Handling of lost to follow-up: Multiple contact information and emergency contacts were collected at the beginning of the study to maintain regular communication with the patients and their guardians to reduce the risk of lost follow-up. If follow-up failed, multiple attempts were made to contact participants via phone, email, or other methods. Once lost to follow-up, multiple imputation methods were used to estimate missing data, and sensitivity analyses were conducted (if possible).
- Conditions
- Acute Liver Failure
- Medical subject headings
- Liver Failure, Acute
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 |
|---|---|---|
| Criteria for Diagnosing Pediatric Acute Liver Failure | This study is a multi-center, nationwide, dual-perspective, observational, open cohort study. It will recruit eligible hospitalized patients from the First Hospital of Jilin University and other participating institutions across the country for observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge Status
Cured:
- Clinical symptoms such as bleeding tendency and hepatic encephalopathy disappear;
- Jaundice resolves (TBil ≤ 2× upper limit of normal); ③ Liver function markers return to baseline; ④ PTA/INR normalizes.
Improved:
① Significant improvement in clinical symptoms like bleeding, and disappearance of hepatic encephalopathy;
- Significant improvement in jaundice, ascites, and other physical signs; ③ Liver function markers show marked improvement (TBIL < 5× upper limit of normal, PTA > 40% or INR < 1.5).
Worsened:
No improvement in symptoms or signs of liver failure, liver function deteriorates, and complications increase or worsen.
Death or death within one week after withdrawal of treatment. Liver Transplantation.
Measured: At discharge (within 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (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
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- liyumei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, liyumei, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778941
- Sponsor's protocol ID
- 24K203-001
- Other IDs
- ChiCTR2400089260
- Acronym
- EPOCH-ALF
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy concerns and the sensitive nature of the data, we do not plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology and Prognostic Analysis of Acute Liver Failure in Chinese Children: a Multi-center Bidirectional Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06778941
- Acronym / sponsor ID
- EPOCH-ALF / 24K203-001
- Conditions
- Acute Liver Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- liyumeiUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 16 Jan 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.
Research Background:
Pediatric acute liver failure (PALF) refers to the sudden onset of severe liver injury in children without known chronic liver disease, leading to multi-system organ dysfunction, with a mortality rate as high as 50%-70%. The etiology of PALF is complex and varied, including infections, metabolic disorders, and toxins. In developed countries, it is often caused by drug and toxin exposure, while in developing countries, viral infections are the primary cause. Additionally, 30%-50% of PALF cases have an unknown etiology, which increases the difficulty of treatment. Current treatment options include medical management, artificial liver support, and liver transplantation. Liver transplantation is the only proven effective treatment, but issues such as organ shortages and the timing of transplantation affect treatment outcomes. Improving diagnostic capabilities for the etiology and exploring optimal treatment strategies are of significant importance in enhancing the clinical success rate of PALF management.
Research Objective:
To explore the etiology and prognostic factors of pediatric acute liver failure (PALF), analyze the relationship between different causes of PALF and prognosis, and the relationship between different treatment modalities and prognosis. This study aims to investigate the correlation between etiology, treatment methods, and outcomes, providing scientific evidence to improve the precision in diagnosis and treatment of PALF and to enhance decision-making and timing judgments for liver transplantation.
Detailed description
Data were organized and analyzed using WindRays statistical software. Quantitative data that followed a normal distribution were expressed as mean ± standard deviation (x ± s), and intergroup comparisons were performed using t-tests. For non-normally distributed quantitative data, median (interquartile range) [M (P25, P75)] was used, and intergroup comparisons were conducted using the Mann-Whitney U test. Qualitative data were presented as frequencies (n) and percentages (%), with intergroup comparisons made using χ² or Fisher's exact test. Multivariate logistic and Cox regression analyses were performed to adjust for potential confounding factors in the association between PALF etiology, treatment, and prognosis. Results were presented as odds ratios (ORs) with 95% confidence intervals (CIs). A multivariate-adjusted restricted cubic spline model was constructed to examine possible non-linear dose-response relationships between PALF etiology, treatment, and prognosis. Variables were selected using stepwise regression, lasso regression, and best subset regression. Risk scoring models were established using regression analysis, nomograms, scoring systems, decision trees, and machine learning algorithms. Sensitivity analyses were conducted using propensity score matching (PSM), regression analysis, and stratified analysis. The predictive efficacy of the model for PALF prognosis was evaluated using the area under the receiver operating characteristic (ROC) curve (AUC), with AUC ≥ 0.80 indicating good predictive value. Data with missing values less than 5% were deleted directly, and data with missing values between 5% and 20% were imputed using multiple imputation methods.
Handling of lost to follow-up: Multiple contact information and emergency contacts were collected at the beginning of the study to maintain regular communication with the patients and their guardians to reduce the risk of lost follow-up. If follow-up failed, multiple attempts were made to contact participants via phone, email, or other methods. Once lost to follow-up, multiple imputation methods were used to estimate missing data, and sensitivity analyses were conducted (if possible).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Criteria for Diagnosing Pediatric Acute Liver Failure | – | –This study is a multi-center, nationwide, dual-perspective, observational, open cohort study. It will recruit eligible hospitalized patients from the First Hospital of Jilin University and other participating institutions across the country for observation. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Criteria for Diagnosing Pediatric Acute Liver Failure
Key inclusion criteria (6 listed)
- According to the diagnostic criteria for PALF, the following conditions must be met:
- ① Severe biochemical liver abnormalities occurring within 8 weeks;
- ② Coagulation disorders uncorrectable by vitamin K: if hepatic encephalopathy is present, prothrombin time (PT) > 15s or international normalized ratio (INR) > 1.5; regardless of the presence of hepatic encephalopathy, PT > 20s or INR > 2.0.
- For patients who were admitted twice, only the information from the first hospitalization will be used.
- Patients with a history of chronic liver disease (e.g., genetic metabolic factors, drug-induced factors) or biliary obstruction that led to the acute episode are categorized under acute liver failure.
Key exclusion criteria (3 listed)
- Age > 18 years;
- Significant data missing (>10%);
- The child's legal guardian refuses participation.
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
Discharge Status
Time frame: At discharge (within 1 week)
Cured: * Clinical symptoms such as bleeding tendency and hepatic encephalopathy disappear; * Jaundice resolves (TBil ≤ 2× upper limit of normal); ③ Liver function markers return to baseline; ④ PTA/INR normalizes. Improved: ① Significant improvement in clinical symptoms like bleeding, and disappearance of hepatic encephalopathy; * Significant improvement in jaundice, ascites, and other physical signs; ③ Liver function markers show marked improvement (TBIL < 5× upper limit of normal, PTA > 40% or INR < 1.5). Worsened: No improvement in symptoms or signs of liver failure, liver function deteriorates, and complications increase or worsen. Death or death within one week after withdrawal of treatment. Liver Transplantation.
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 16 Jan 2025.
- Individual participant dataSharing planned: No. Due to privacy concerns and the sensitive nature of the data, we do not plan to share individual participant data with other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure, run by liyumei.
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 6 inclusion and 3 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 16 Jan 2025. 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 Yumei Professor Li (+86 15804301227, ym_li@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge Status (time frame: At discharge (within 1 week)). 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 16 Jan 2025.