Clinical Study of Pediatric Acute Liver Failure

NCT06893042 | Enrolling By Invitation

• 1 other identifier: 346A01
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 months

Eligibility Criteria

• Age: 1 Minute - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The children under the age of 18 diagnosed with acute liver failure in Guangzhou Women's and Children's Medical Center.

You may qualify if:

• （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.

Sponsors & Collaborators

• Fansen Zeng: lead

Study Sites (1)

Guangzhou Women's and Children's Medical Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2026/09/01-2031/09/01

Locations

CN (1)