Registry Study for Optimal Management of Liver Failure in the Chinese Population

NCT ID: NCT05740696

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-06

Study Completion Date

2028-12-30

Brief Summary

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Liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. This study intends to construct a real-world case registry database of inpatients with liver failure based on an electronic clinical data collection system through a multicenter collaborative network to study the clinical characteristics, epidemiology of bacterial and fungal infections, the impact of sarcopenia on clinical prognosis, and optimization of treatment strategies such as antiviral and artificial liver in Chinese inpatients with liver failure. The cohort and experience generated from this study will be used as a support for a series of future studies to focus on clinical issues such as infection, end-stage liver disease combined with organ failure, and early warning of critically ill patients.

Detailed Description

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Conditions

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Liver Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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ALF

acute liver failure

ALF

Intervention Type PROCEDURE

Acute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks

SALF

subacute liver failure

SALF

Intervention Type PROCEDURE

The onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks

ACLF

acute-on-chronic liver failure

ACLF

Intervention Type PROCEDURE

On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period

Interventions

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ALF

Acute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks

Intervention Type PROCEDURE

SALF

The onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks

Intervention Type PROCEDURE

ACLF

On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients with a diagnosis consistent with liver failure and pre-liver failure:

* Extreme weakness with significant gastrointestinal symptoms such as anorexia, vomiting and abdominal distention;
* Elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) with progressive jaundice (TBil≥85.5 μmol/L);
* Bleeding tendency with PTA ≤ 60% or INR ≥ 1.5.

Exclusion Criteria

* An event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingli He, Pro.

Role: STUDY_DIRECTOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Ankang Central Hospital

Ankang, , China

Site Status RECRUITING

Xiangya Hospital of Central South University

Changsha, , China

Site Status NOT_YET_RECRUITING

Hanzhong 3201 Hospital

Hanzhong, , China

Site Status NOT_YET_RECRUITING

Qilu Hospital of Shandong University

Jinan, , China

Site Status NOT_YET_RECRUITING

First Hospital of Lanzhou University

Lanzhou, , China

Site Status NOT_YET_RECRUITING

Weinan Central Hospital

Weinan, , China

Site Status NOT_YET_RECRUITING

Air Force Medical University Tangdu Hospital

Xi'an, , China

Site Status NOT_YET_RECRUITING

Shaanxi provincial people's hospital

Xi'an, , China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status RECRUITING

Xi 'an International Medical Center Hospital

Xi'an, , China

Site Status NOT_YET_RECRUITING

Xianyang Central Hospital

Xianyang, , China

Site Status RECRUITING

The Affiliated Hospital of Yan'an University

Yanan, , China

Site Status NOT_YET_RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Yingli He, Pro.

Role: CONTACT

0086-18991232863

Juan Li, M.D.

Role: CONTACT

0086-18209272726

Facility Contacts

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Yingli He, M.D.,Ph.D

Role: primary

0086-18991232863

Juan Li, M.D.

Role: backup

0086-18209272726

Zicheng Jiang

Role: primary

Ruochan Chen

Role: primary

Yongmei Lin

Role: primary

Yuchen Fan

Role: primary

Xiaorong Mao

Role: primary

Hongbing Li

Role: primary

Hong Du

Role: primary

Yu Li

Role: primary

Fanpu Ji

Role: primary

15319435860

Zhansheng Jia

Role: primary

Wenxuan Zhao

Role: primary

Na Liu

Role: primary

Xiangchun Ding

Role: primary

Other Identifiers

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XJTU1AF2023LSK-019

Identifier Type: -

Identifier Source: org_study_id

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