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Clinical Trials/NCT06893042
NCT06893042Enrolling By InvitationNot Applicable

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

Fansen Zeng1 site in 1 country7 target enrollmentStarted: September 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
7
Locations
1
Primary Endpoint
With the changes of various indicators such as blood ammonia albumin lactic acid coagulation function with the implementation of treatment

Study Overview

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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Minute to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fansen Zeng
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Fansen Zeng

associate chief physician

Guangzhou Women and Children's Medical Center

Study Sites (1)

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