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Enrolling by invitation NCT06893042

Clinical Study of Pediatric Acute Liver Failure

Observational Acute Liver Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Liver Failure. Basic parameters: 1 Minute — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Study on the Real Word of Acute Liver Failure in Children

Overview

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.

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

  • (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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Guangzhou Women's and Children's Medical Center — Guangzhou

Identifiers

NCT: NCT06893042 · 346A01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗