A Study of AARC Standards on Diagnosis and Treatment of Patients With HBV-ACLF in China (AARC China Study)

A Study of APASL ACLF Research Consortium (AARC) Standards on Diagnosis and Treatment of Patients With Hepatic B Virus Related Acute on Chronic Liver Failure (HBV-ACLF) in China (AARC China Study)： a Multicentre Prospective Cohort Study

The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.

Study Overview

• Status: Recruiting
• Conditions: HBV; Acute on Chronic Liver Failure
• Intervention / Treatment: Other: No intervention

Detailed Description

Acute on chronic liver failure (ACLF) is a clinically critical illness and has been extensively researched around the world. However, there is a potential "communication barrier" in the ACLF study; that is, different countries and regions, or different research collaboration groups, follow different ACLF definitions and related standards, making researchers in this field confuse in understanding the research value of relevant research and interpreting the research results. Important differences exist in the Asia-Pacific region and North America and Europe, such as the etiology, the clinical characteristics of the patient group, the requirements for cirrhosis, and the predisposing factors of the disease, making it necessary for China or the Asia-Pacific region to develop appropriate ACLF diagnosis standards and prognosis. In recent years, Chinese experts have also focused on the research progress of APASL ACLF Research Consortium (AARC) in the Asia-Pacific region. It is found that the AARC standards are more suitable for the diagnosis and treatment of patients with ACLF in China than the Western standards. The ACLF prediction model (TPPM model) established by Professor Qin.N's team predicts that the prognostic efficacy of patients with HBV-ACLF is significantly better than that of Western prognosis. The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Qin Ning, MD., PhD.; Phone Number: 0086 2783662391; Email: qning@vip.sina.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qin Ning, Prof.; Phone Number: 862883662391; Email: qning@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with HBV-related acute-on-chronic liver failure

Description

Inclusion Criteria:

• Chronic liver disease: Chronic hepatitis B

• Acute deterioration of liver function: more than one of the below criteria

  1. development of new ascites within 4 weeks or re-emergence of ascites who have previous well controlled ascites (greater than or equal to grade 2 or 3; International ascites club criteria)
  2. development of hepatic encephalopathy
  3. development of gastrointestinal hemorrhage
  4. development of jaundice (serum bilirubin greater than or equal to 3mg/dl)
  5. development of bacterial infection
• spontaneous bacteremia: positive blood cultures without a source of infection
• spontaneous bacterial peritonitis: ascitic fluid polymorphonuclear cells >250/µL
• lower respiratory tract infections: new pulmonary infiltrate in the presence of: i) at least one respiratory symptom (cough, sputum production, dyspnea, pleuritic pain) with ii) at least one finding on auscultation (rales or crepitation) or one sign of infection (core body temperature >38_C or less than 36_C, shivering, or leukocyte count >10,000/mm3 or <4,000/mm3) in the absence of antibiotics
• Clostridium difficile Infection: diarrhea with a positive C. difficile assay
• bacterial entero-colitis: diarrhea or dysentery with a positive stool culture for Salmonella, Shigella, Yersinia, Campylobacter, or pathogenic E. coli;
• soft-tissue/skin Infection: fever with cellulitis
• urinary tract infection (UTI): urine white blood cell >15/high-power field with either positive urine gram stain or culture;
• intra-abdominal infections: diverticulitis, appendicitis, cholangitis, etc.
• other infections not covered above;
• fungal infections as a separate category.

Exclusion Criteria:

• Patients who do not have chronic liver disease
• Patients who have hepatocellular carcinoma
• Patients who admitted for extrahepatic manifestations
• Patients who have HIV infection
• Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HBV-ACLF Group; Patients with HBV related acute on chronic liver failure	Other: No intervention; This is an observation study, no intervention will be indicated during diagnosis and treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-liver transplant mortality	Non-liver transplant mortality rate at 30 days, 90 days	30 days, 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression of Chronic liver disease	Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)	3 years

Collaborators and Investigators

• Sponsor: Qin Ning
• Investigators: Study Director: Qin Ning, MD., PhD., Department of infectious disease, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: April 13, 2019
• First Submitted That Met QC Criteria: August 11, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: acute on chronic liver failure; APASL ACLF Research Consortium; Diagnosis and treatment standard; HBV-ACLF
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: AARC China Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No