Etiology and Prognostic Analysis of Acute Liver Failure in Chinese Children

NCT06778941 | Not Yet Recruiting

• 2 other identifiers: 24K203-001ChiCTR2400089260
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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%. 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.

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  At discharge (within 1 week)

Study Arms (1)

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.

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Criteria for Diagnosing Pediatric Acute Liver Failure

You may qualify if:

• 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.

You may not qualify if:

• Age \> 18 years;
• Significant data missing (\>10%);
• The child's legal guardian refuses participation.

Sponsors & Collaborators

• liyumei: lead

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Yumei Professor Li

CONTACT

+86 15804301227; ym_li@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share